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| ID | Type | Description | Link |
|---|---|---|---|
| NU-04L2 | |||
| STU00007415 | Other Identifier | Northwestern University IRB# |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
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 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with complete response, partial response, or stable disease continue to receive pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Carboplatin + pemetrexed + bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | 5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival | Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point. | Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall Response Rate (ORR) of patients treated with carboplatin, pemetrexed, and bevacizumab combination is defined as the number of patients who's best response is a Complete Response (CR) plus Partial Response (PR)as recorded from the start of treatment until disease progression as assessed by RECIST 1.0. CR=Disappearance of all target lesions for a minimum of 4 weeks. PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions for a minimum of 4 weeks, taking as reference the baseline sum LD. No simultaneous increase in the size of any lesion or the appearance of a new lesion may occur. |
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DISEASE CHARACTERISTICS:
Histologically* or cytologically* confirmed non-small cell lung cancer
Any histology, except squamous cell carcinoma, allowed
No histology in close proximity to a major vessel or cavitation NOTE: *Histologic or cytologic elements may be established on metastatic tumor aspirates or biopsy
Meets 1 of the following stage criteria:
Measurable or non-measurable disease
No known CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No myocardial infarction within the past 6 months
No New York Heart Association class II-IV congestive heart failure
No unstable angina pectoris
No serious cardiac arrhythmia requiring medication
No stroke within the past 6 months
No peripheral vascular disease ≥ grade 2
No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)
No history of thrombotic disorders
No other clinically significant cardiovascular disease
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Recovered from all prior therapy
More than 4 weeks since prior and no concurrent participation in another experimental drug study
No aspirin or other nonsteroidal anti-inflammatory drug (NSAID) 2 days before and 2 days after each pemetrexed disodium infusion (5 days before and 2 days after each pemetrexed disodium infusion for NSAIDs with a long half-life [e.g., naproxen, rofecoxib, or celecoxib])
No concurrent therapeutic anticoagulation
No concurrent administration of any of the following:
Chronic daily treatment with aspirin (> 325 mg per day)
NSAIDs known to inhibit platelet function, including any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Jyoti D. Patel | Robert H. Lurie Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States | ||
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The study opened for accrual on June 1, 2005 with an accrual goal of 50 patients. The first patient enrolled started treatment on July 28, 2005. The study was closed permanently on July 10, 2007 when accrual had been met with 51 patients registered and 50 patients treated on study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Carboplatin + Pemetrexed + Bevacizumab | Carboplatin + Pemetrexed + Bevacizumab Patients will receive 6 cycles where (1 cycle is 21 days) of : Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days: Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| carboplatin | Drug | Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks) |
|
| pemetrexed | Drug | Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks) |
|
|
| Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months) |
| Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment | To characterize the toxicity profile of carboplatin, pemetrexed and bevacizumab combination treatment. Toxicity data will be collected from initiation of treatment, every cycle, until 30 days post last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). Only toxicity determined to be a least possibility related to at least one study drug and grade 3 or 4 was collected for this outcome measure. In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51) |
| Overall Survival Rate | Overall Survival (OS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment is defined from the time of registration to the study until death from any cause. Patients that are lost to follow up will be censored from last documentation of survival status. | During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death. |
| Duration of Response | Duration of Response for patients treated with the combination of carboplatin, pemetrexed and bevacizumab is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date of documented progressive disease. | From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51. |
| Rush Cancer Institute at Rush University Medical Center |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Evanston Northwestern Healthcare - Evanston Hospital | Evanston | Illinois | 60201-1781 | United States |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068-1174 | United States |
| Started Treatment |
|
| Completed 6 Cycles |
|
| Went Into Maintenance Phase |
|
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up for 5 Years |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Carboplatin + Pemetrexed + Bevacizumab | Carboplatin + Pemetrexed + Bevacizumab Patients will receive 6 cycles where (1 cycle is 21 days) of : Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days: Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Median Progression Free Survival | Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point. | Posted | Median | 95% Confidence Interval | Months | Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Response Rate | Overall Response Rate (ORR) of patients treated with carboplatin, pemetrexed, and bevacizumab combination is defined as the number of patients who's best response is a Complete Response (CR) plus Partial Response (PR)as recorded from the start of treatment until disease progression as assessed by RECIST 1.0. CR=Disappearance of all target lesions for a minimum of 4 weeks. PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions for a minimum of 4 weeks, taking as reference the baseline sum LD. No simultaneous increase in the size of any lesion or the appearance of a new lesion may occur. | One patient received less than one cycle and was determined to not be evaluable for this outcome measure. | Posted | Count of Participants | Participants | Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months) |
| ||||||||||||||||||||||||||||
| Secondary | Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment | To characterize the toxicity profile of carboplatin, pemetrexed and bevacizumab combination treatment. Toxicity data will be collected from initiation of treatment, every cycle, until 30 days post last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). Only toxicity determined to be a least possibility related to at least one study drug and grade 3 or 4 was collected for this outcome measure. In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | This includes AEs observed before there was an amendment of the protocol to exclude patients with histories of diverticulitis or clinically significant diverticular disease. Any patient that received one dose of study drug is evaluable for this objective. | Posted | Count of Participants | Participants | From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51) |
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate | Overall Survival (OS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment is defined from the time of registration to the study until death from any cause. Patients that are lost to follow up will be censored from last documentation of survival status. | Posted | Median | 95% Confidence Interval | Months | During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death. |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of Response for patients treated with the combination of carboplatin, pemetrexed and bevacizumab is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date of documented progressive disease. | Patients with response were included in this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51. |
|
| ||||||||||||||||||||||||||
| Post-Hoc | Progression Free Survival at 6, 12, 18, 24 Months | Progression Free Survival (PFS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment is defined as the percentage of patients without progression at the following time points from registration to the study: 6 months 12 months 18 months 24 months. | One patient received less than one cycle and was determined to not be evaluable for this objective. | Posted | Number | percentage of patients with PFS | 6, 12,18, and 24 months from treatment initiation |
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| Post-Hoc | Overall Survival Rate at 6, 12, 18, and 24 Months | Overall Survival (OS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment will be defined as the percentage of patients with documentation of status of alive at the following timepoints from registration to the study: 6 months 12 months 18 months 24 months | Posted | Number | percentage of patients alive | 6, 12,18, and 24 months from treatment initiation |
|
|
Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment With Carboplatin + Pemetrexed + Bevacizumab | Carboplatin + Pemetrexed + Bevacizumab Patients will receive 6 cycles where (1 cycle is 21 days) of : Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days: Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle | 41 | 50 | 22 | 50 | 50 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Puesdogout | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heart Attack | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bowel Obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acute and Chronic Cholelithiasis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Experienced before protocol amended to exclude patients with a history of diverticulitis |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Patient also with Nausea, Constipation and anemia |
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| Epistaxis | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Osteomylitis of the right great toe | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Axillary Abscess | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Seizures | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Viral Pneumonitis resulting in Death | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia/death | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils (Neutropenia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin (Anemia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Leukocytes (Total white blood cells) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Platelets (Thrombocytopenia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Weight Loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss/Alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Epistaxis (Nosebleed) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Tract Infection NOS | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Alkaline Phosphastase Increase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Transaminase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| ALT Increase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| AST Increase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Albumin Decrease | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Creatinine, Serum-high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Calcium, Serum-low (Hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Glucose, Serum-high (Hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Neuropathy: Sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Mood Alteration - Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dyspnea (Shortness of Breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Watery Eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Office | Northwestern University | 312-695-1301 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| 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 |
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| 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 |
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| 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 |
|
| Unknown or Not Reported |
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