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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00670 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000626346 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving pemetrexed together with carboplatin and bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed together with carboplatin and bevacizumab works as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or partial or complete response after 6 courses may continue to receive pemetrexed disodium and bevacizumab every 21 days in the absence of disease progression or unacceptable toxicity.
Tissue and blood samples are collected at baseline for pharmacogenetic analysis. Blood samples are used to evaluate functionally relevant polymorphisms in the genes that encode proteins involved in the transport and activation of pemetrexed disodium and in the genes that encode proteins involved in susceptibility to hypertension induced by bevacizumab. Tissue samples are used to evaluate expression and polymorphisms in pemetrexed disodium target genes (TS, DHFR, and GARFT).
Quality of life is assessed at baseline and periodically during study.
After completion of study therapy, patients are followed periodically for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pemetrexed + carboplatin + bevacizumab | Experimental | Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or partial or complete response after 6 courses may continue to receive pemetrexed disodium and bevacizumab every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological |
| ||
| carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival at 6 Months | Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Confirmed Tumor Response Defined as an Objective Status of Complete Response or Partial Response on Two Consecutive Evaluations | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, persistence of one or more non-target lesions, and no new lesions; or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, no appearance of one/more new lesions, unequivocal progression of existing non-target lesions, and no new lesions. |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed nonsquamous cell non-small cell lung cancer (NSCLC)
Stage IIIB (with pleural effusion) or IV disease
Squamous cell carcinomas not allowed
Clinically significant effusion (e.g., symptomatic pleural effusion or ascites) allowed provided it is drained before study treatment
Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan
No symptomatic, untreated, or uncontrolled CNS metastases
Willing to enroll in NCCTG-N0392
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Life expectancy ≥ 12 weeks
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal
AST and ALT ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement)
Creatinine clearance ≥ 45 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Able to take folic acid, vitamin B_12 supplementation, or dexamethasone
Able to complete questionnaire(s) alone or with assistance
Willing to provide biologic specimens as required by the study
Willing to return to NCCTG participating center for follow-up
No clinically significant infection
No serious, nonhealing wounds, ulcers, or bone fractures
No seizure disorder
No second primary malignancy within the past 5 years, except for any of the following:
Carcinoma in situ of the cervix
Nonmelanomatous skin cancer
Low-grade (Gleason score ≤ 6) localized prostate cancer (no nodal involvement)
Previously treated stage I breast cancer
No concurrent severe and/or uncontrolled medical condition, including any of the following:
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 12 months
No diverticulitis within the past 12 months
No stroke within the past 6 months
No significant traumatic injury within the past 8 weeks
Not at greater than normal risk of bleeding
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior radiotherapy to > 25% of bone marrow
More than 2 weeks since prior radiotherapy and recovered (alopecia allowed)
At least 2 weeks since prior WBRT
At least 3 days since prior gamma knife radiosurgery (without WBRT) for brain metastases
More than 4 weeks since prior administration of live or attenuated viral vaccine
More than 8 weeks since prior major surgery (e.g., laparotomy) or open biopsy (> 4 weeks since minor surgery)
No prior chemotherapy or systemic therapy for advanced lung cancer, except neoadjuvant or adjuvant chemotherapy
No NSAID's 2 days prior to (5 days for long-acting NSAID's), the day of, and 2 days following protocol treatment
More than 12 months since prior neoadjuvant therapy, adjuvant therapy, systemic chemotherapy, chemoradiotherapy, immunotherapy, or biologic therapy
No concurrent anticoagulants
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| Name | Affiliation | Role |
|---|---|---|
| Grace K. Dy, MD | Roswell Park Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Aurora Presbyterian Hospital |
Three participants who never received any study treatment are excluded from all analyses.
Sixty-five (65) participants were enrolled between December 12, 2008 and October 1, 2010. Final analysis as of November 6, 2012, was reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed + Carboplatin + Bevacizumab | Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| pemetrexed disodium | Drug |
|
| Duration of study until progression (up to 5 years) |
| Duration of Response | Duration of response for responders was defined as the time from the date of the first objective status assessment of a confirmed CR or PR to the first date of disease progression. Duration of response will be censored at the date of last post-therapy follow-up visit for responders who have not had disease progression. Duration of response will be calculated for all evaluable patients who have achieved an objective confirmed response. | Up to 5 years |
| Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients | Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. | Up to 2.5 years |
| Time to Treatment Failure | Time to treatment failure was defined to be the time from date of registration to the date at which the patient is removed from the treatment due to progression, toxicity, refusal or death from any cause. | Up to 5 years |
| Progression-free Survival | Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression. | Up to 5 years |
| Overall Survival | Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up. | Up to 5 years |
| Change From Baseline to Cycle 3 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale | Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | Baseline and Cycle 3 |
| Change From Baseline to Cycle 5 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale | Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | Baseline and Cycle 5 |
| Change From Baseline to Cycle 3 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA) | The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | Baseline and Cycle 3 |
| Change From Baseline to Cycle 5 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA) | The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | Baseline and Cycle 5 |
| Change From Baseline to Cycle 3 in Fatigue Assessed by Treatment-specific Adverse Events Scale | The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | Baseline and Cycle 3 |
| Change From Baseline to Cycle 5 in Fatigue Assessed by Treatment-specific Adverse Events Scale | The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | Baseline and Cycle 5 |
| Change From Baseline to Cycle 3 in Neuropathy Assessed by Treatment-specific Adverse Events Scale | The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | Baseline and Cycle 3 |
| Change From Baseline to Cycle 5 in Neuropathy Assessed by Treatment-specific Adverse Events Scale | The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | Baseline and Cycle 5 |
| Change From Baseline to Cycle 3 in Nausea Assessed by Treatment-specific Adverse Events Scale | The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | Baseline and Cycle 3 |
| Change From Baseline to Cycle 5 in Nausea Assessed by Treatment-specific Adverse Events Scale | The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | Baseline and Cycle 5 |
| Aurora |
| Colorado |
| 80012 |
| United States |
| Boulder Community Hospital | Boulder | Colorado | 80301-9019 | United States |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | 80933 | United States |
| St. Anthony Central Hospital | Denver | Colorado | 80204 | United States |
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | United States |
| St. Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| CCOP - Colorado Cancer Research Program | Denver | Colorado | 80224-2522 | United States |
| Swedish Medical Center | Englewood | Colorado | 80110 | United States |
| Front Range Cancer Specialists | Fort Collins | Colorado | 80528 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | 81502 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | United States |
| Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | 80501 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | 81004 | United States |
| North Suburban Medical Center | Thornton | Colorado | 80229 | United States |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Illinois CancerCare - Bloomington | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Illinois CancerCare - Canton | Canton | Illinois | 61520 | United States |
| Illinois CancerCare - Carthage | Carthage | Illinois | 62321 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare - Eureka | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare - Galesburg | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare - Havana | Havana | Illinois | 62644 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare - Macomb | Macomb | Illinois | 61455 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| Illinois CancerCare - Monmouth | Monmouth | Illinois | 61462 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Illinois CancerCare - Community Cancer Center | Normal | Illinois | 61761 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | 61350 | United States |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| Illinois CancerCare - Peru | Peru | Illinois | 61354 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Illinois CancerCare - Princeton | Princeton | Illinois | 61356 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| Saint Joseph Regional Medical Center | Mishawaka | Indiana | 46545-1470 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa | 50325 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa | 52501 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | 49431 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Dickinson County Healthcare System | Iron Mountain | Michigan | 49801 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | United States |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | 48144 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | United States |
| Mercy Memorial Hospital - Monroe | Monroe | Michigan | 48162 | United States |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | United States |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | United States |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| Immanuel St. Joseph's | Mankato | Minnesota | 56002 | United States |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405-5309 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| Great Falls | Montana | 59405 | United States |
| Northern Montana Hospital | Havre | Montana | 59501 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | United States |
| Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota | 58201 | United States |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | United States |
| Wood County Oncology Center | Bowling Green | Ohio | 43402 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| North Coast Cancer Care - Clyde | Clyde | Ohio | 43410 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| CCOP - Dayton | Dayton | Ohio | 45420 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Community Cancer Center | Elyria | Ohio | 44035 | United States |
| Hematology Oncology Center | Elyria | Ohio | 44035 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Wayne Hospital | Greenville | Ohio | 45331 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537-1839 | United States |
| St. Luke's Hospital | Maumee | Ohio | 43537 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Fisher-Titus Medical Center | Norwalk | Ohio | 44857 | United States |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | United States |
| Toledo Clinic - Oregon | Oregon | Ohio | 43616 | United States |
| North Coast Cancer Care, Incorporated | Sandusky | Ohio | 44870 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | United States |
| St. Anne Mercy Hospital | Toledo | Ohio | 43623 | United States |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Fulton County Health Center | Wauseon | Ohio | 43567 | United States |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | United States |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | 22401 | United States |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54301-3526 | United States |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | 54303 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin | 54601 | United States |
| Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin | 54221-1450 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All participants who received treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed + Carboplatin + Bevacizumab | Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Gender | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status | Count of Participants | Participants |
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| Histologic type | Count of Participants | Participants |
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| Non-small-cell lung cancer stage (TNM 6th edition) | Stage IIIB: The cancer is continuing to spread from the lungs to the lymph nodes or to nearby structures and organs, such as the heart, trachea and esophagus. Stage IV: The cancer has metastasized throughout the body and may now affect the liver, bones or brain. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival at 6 Months | Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. | The first 55 participants who met the eligibility criteria and have started the study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Proportion of Confirmed Tumor Response Defined as an Objective Status of Complete Response or Partial Response on Two Consecutive Evaluations | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, persistence of one or more non-target lesions, and no new lesions; or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, no appearance of one/more new lesions, unequivocal progression of existing non-target lesions, and no new lesions. | All participants who met the eligibility criteria, have started the study treatment and have post-baseline disease assessments. | Posted | Number | 95% Confidence Interval | percentage of participants | Duration of study until progression (up to 5 years) |
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| Secondary | Duration of Response | Duration of response for responders was defined as the time from the date of the first objective status assessment of a confirmed CR or PR to the first date of disease progression. Duration of response will be censored at the date of last post-therapy follow-up visit for responders who have not had disease progression. Duration of response will be calculated for all evaluable patients who have achieved an objective confirmed response. | All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
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| Secondary | Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients | Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. | All participants who received treatment. | Posted | Number | particpants | Up to 2.5 years |
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| Secondary | Time to Treatment Failure | Time to treatment failure was defined to be the time from date of registration to the date at which the patient is removed from the treatment due to progression, toxicity, refusal or death from any cause. | All participants who met the eligibility criteria and have started the study treatment. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
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| Secondary | Progression-free Survival | Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression. | All participants who met the eligibility criteria and have started the study treatment. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
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| Secondary | Overall Survival | Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up. | All participants who met the eligibility criteria and have started the study treatment. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
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| Secondary | Change From Baseline to Cycle 3 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale | Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LCSS data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 3 |
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| Secondary | Change From Baseline to Cycle 5 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale | Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LCSS data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 5 |
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| Secondary | Change From Baseline to Cycle 3 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA) | The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LASA data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 3 |
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| Secondary | Change From Baseline to Cycle 5 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA) | The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LASA data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 5 |
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| Secondary | Change From Baseline to Cycle 3 in Fatigue Assessed by Treatment-specific Adverse Events Scale | The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 fatigue data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 3 |
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| Secondary | Change From Baseline to Cycle 5 in Fatigue Assessed by Treatment-specific Adverse Events Scale | The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 fatigue data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 5 |
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| Secondary | Change From Baseline to Cycle 3 in Neuropathy Assessed by Treatment-specific Adverse Events Scale | The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 neuropathy data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 3 |
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| Secondary | Change From Baseline to Cycle 5 in Neuropathy Assessed by Treatment-specific Adverse Events Scale | The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 neuropathy data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 5 |
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| Secondary | Change From Baseline to Cycle 3 in Nausea Assessed by Treatment-specific Adverse Events Scale | The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 nausea data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 3 |
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| Secondary | Change From Baseline to Cycle 5 in Nausea Assessed by Treatment-specific Adverse Events Scale | The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5. | All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 nausea data. | Posted | Median | Full Range | units on a scale | Baseline and Cycle 5 |
|
|
2.5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pemetrexed + Carboplatin + Bevacizumab | Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. | 10 | 62 | 62 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischemia | Cardiac disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAEV4.0 | Systematic Assessment |
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| Abdominal infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | CTCAEV4.0 | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAEV4.0 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | CTCAEV4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAEV4.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAEV4.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAEV4.0 | Systematic Assessment |
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| Hemolysis | Blood and lymphatic system disorders | CTCAEV4.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAEV4.0 | Systematic Assessment |
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| Cardiac disorder | Cardiac disorders | CTCAEV4.0 | Systematic Assessment |
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| Myocardial ischemia | Cardiac disorders | CTCAEV4.0 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | CTCAEV4.0 | Systematic Assessment |
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| Wolff-Parkinson-White syndrome | Cardiac disorders | CTCAEV4.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | CTCAEV4.0 | Systematic Assessment |
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| Dry eye syndrome | Eye disorders | CTCAEV4.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Colonic obstruction | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Colonic perforation | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Ear, nose and throat examination abnormal | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Jejunal hemorrhage | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Rectal pain | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Typhlitis | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Disease progression | General disorders | CTCAEV4.0 | Systematic Assessment |
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| Edema limbs | General disorders | CTCAEV4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAEV4.0 | Systematic Assessment |
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| Fever | General disorders | CTCAEV4.0 | Systematic Assessment |
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| Gallbladder obstruction | Hepatobiliary disorders | CTCAEV4.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | CTCAEV4.0 | Systematic Assessment |
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| Infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAEV4.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAEV4.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAEV4.0 | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAEV4.0 | Systematic Assessment |
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| Laboratory test abnormal | Investigations | CTCAEV4.0 | Systematic Assessment |
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| Leukocyte count decreased | Investigations | CTCAEV4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAEV4.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAEV4.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAEV4.0 | Systematic Assessment |
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| Weight loss | Investigations | CTCAEV4.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
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| Blood glucose increased | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
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| Serum magnesium decreased | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
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| Serum potassium increased | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
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| Serum sodium decreased | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAEV4.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Taste alteration | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Renal and urinary disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Protein urine positive | Renal and urinary disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Bronchial hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Hiccough | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Pharyngeal examination abnormal | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | CTCAEV4.0 | Systematic Assessment |
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| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAEV4.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Peripheral ischemia | Vascular disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAEV4.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace K. Dy, M.D. | Roswell Park Cancer Institute | 507-284-9265 | grace.dy@roswellpark.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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