Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| S0635 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Erlotinib 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib and Bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological |
| ||
| erlotinib hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From date of registration to maximum of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | From date of registration to maximum of 3 years | |
| Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease | Images for response assessed by the central computer-assisted image-analysis system were never collected. |
Not provided
DISEASE CHARACTERISTICS:
Biopsy-proven* bronchioloalveolar carcinoma (BAC) or BAC variants (e.g., adenocarcinoma with BAC features, BAC with invasive adenocarcinoma) meeting the following criteria:
Incompletely resected or unresectable disease
No component of squamous cell carcinoma
Disease staged as 1 of the following:
Stage IIIB disease (T4 [cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor], any N, M0)
Stage IV disease (any T, any N, M1 [distant metastases present])
Tumor may be multifocal or diffuse NOTE: *Cytology specimens, including bronchial brushing, washings, or fine needle aspiration specimens, alone are not acceptable for diagnosis
Measurable or nonmeasurable disease by chest CT scan
Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids
PATIENT CHARACTERISTICS:
Zubrod performance status 0-2
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Total bilirubin normal
AST or AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases are present)
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1 g by 24-hour urine collection
Willing to provide prior smoking history
No hemoptysis ≥ ½ teaspoon within the past 28 days
No clinical history of pulmonary or upper respiratory hemorrhage > grade 2 within the past 6 months or > grade 1 within the past 28 days
No history of thromboses or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding
No uncontrolled hypertension
No serious nonhealing wound, ulcer, or bone fracture
No other prior malignancy except for any of the following:
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Howard L. West, MD | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente - Deer Valley | Antioch | California | 94531 | United States | ||
| Alta Bates Summit Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | West HJ, Moon J, Hirsch FR, et al.: SWOG S0635 and S0636: Phase II trials in advanced-stage NSCLC of erlotinib (OSI-774) and bevacizumab in bronchioloalveolar carcinoma (BAC) and adenocarcinoma with BAC features (adenoBAC), and in never-smokers with primary NSCLC adenocarcinoma (adenoCa). [Abstract] J Clin Oncol 30 (Suppl 15): A-7517, 2012. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib and Bevacizumab | Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 2, 2011 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| From date of registration to maximum of 3 years |
| Frequency and Severity of Toxicities | From date of registration to maximum of 3 years |
| Berkeley |
| California |
| 94704 |
| United States |
| Peninsula Medical Center | Burlingame | California | 94010 | United States |
| Kaiser Permanente - Fremont | Fremont | California | 94538 | United States |
| Kaiser Permanente Medical Center - Hayward | Hayward | California | 94545 | United States |
| Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville | California | 95901 | United States |
| Kaiser Permanente Medical Center - Oakland | Oakland | California | 94611 | United States |
| Valley Medical Oncology Consultants - Pleasanton | Pleasanton | California | 94588 | United States |
| Kaiser Permanente Medical Center - Redwood City | Redwood City | California | 94063 | United States |
| Kaiser Permanente Medical Center - Richmond | Richmond | California | 94801 | United States |
| Kaiser Permanente Medical Center - Roseville | Roseville | California | 95661 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| South Sacramento Kaiser-Permanente Medical Center | Sacramento | California | 95823 | United States |
| Kaiser Permanente Medical Center - Sacramento | Sacramento | California | 95825 | United States |
| Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco | California | 94115 | United States |
| California Pacific Medical Center - California Campus | San Francisco | California | 94118 | United States |
| Kaiser Permanente Medical Center - Santa Teresa | San Jose | California | 95119 | United States |
| Kaiser Foundation Hospital - San Rafael | San Rafael | California | 94903 | United States |
| Sutter Health - Western Division Cancer Research Group | San Rafael | California | 94903 | United States |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara | California | 95051 | United States |
| Kaiser Permanente Medical Center - Santa Rosa | Santa Rosa | California | 95403 | United States |
| Kaiser Permanente Medical Center - South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente Medical Facility - Stockton | Stockton | California | 95210 | United States |
| Tahoe Forest Cancer Center | Truckee | California | 96161 | United States |
| Kaiser Permanente Medical Center - Vacaville | Vacaville | California | 95688 | United States |
| Kaiser Permanente Medical Center - Vallejo | Vallejo | California | 94589 | United States |
| Sutter Solano Medical Center | Vallejo | California | 94589 | United States |
| Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Northside Hospital Cancer Center | Atlanta | Georgia | 30342-1611 | United States |
| Saint Joseph's Hospital of Atlanta | Atlanta | Georgia | 30342-1701 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342 | United States |
| WellStar Cobb Hospital | Austell | Georgia | 30106 | United States |
| John B. Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia | 30033 | United States |
| Piedmont Fayette Hospital | Fayetteville | Georgia | 30214 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Gwinnett Medical Center | Lawrenceville | Georgia | 30045 | United States |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | United States |
| Southern Regional Medical Center | Riverdale | Georgia | 30274-2600 | United States |
| Harbin Clinic Cancer Center - Medical Oncology | Rome | Georgia | 30165 | United States |
| Kaiser Permanente - Moanalua Medical Center and Clinic | Honolulu | Hawaii | 96819 | United States |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | 62781-0001 | 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 - Liberal | Liberal | Kansas | 67901 | 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 |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas | 67401 | United States |
| Cotton-O'Neil Cancer Center | Topeka | Kansas | 66606 | 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 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | 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 |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| Mecosta County Medical Center | Big Rapids | Michigan | 49307 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| Mercy General Health Partners | Muskegon | Michigan | 49443 | 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 |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59102 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | 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 |
| 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 |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Pardee Memorial Hospital | Hendersonville | North Carolina | 28791 | United States |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | 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 |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| Sandra L. Maxwell Cancer Center | Cedar City | Utah | 84720 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | United States |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | United States |
| Columbia Basin Hematology | Kennewick | Washington | 99336 | United States |
| Skagit Valley Hospital Cancer Care Center | Mount Vernon | Washington | 98274 | United States |
| Harrison Poulsbo Hematology and Onocology | Poulsbo | Washington | 98370 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Minor and James Medical, PLLC | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Group Health Central Hospital | Seattle | Washington | 98112 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98122-4307 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Evergreen Hematology and Oncology, PS | Spokane | Washington | 99218 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801-2028 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| Eligible |
|
| Eligible and Began Protocol Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib and Bevacizumab | Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Histology | Count of Participants | Participants |
| ||||||||||||||||||
| Performance Status | 0: Fully active, able to carry on all pre-disease performance without restriction.
| Count of Participants | Participants |
| |||||||||||||||||
| Smoking History | Count of Participants | Participants |
| ||||||||||||||||||
| Stage | Patients must have selected Stage IIIB disease or Stage IV disease as outlined below (AJCC Cancer Staging Manual, 6th Edition, 2002): IIIB
Stage IV
NOTE: Any disease that is recurrent after surgery or radiation is classified as Stage IV. | Count of Participants | Participants |
| |||||||||||||||||
| Weight Loss Last 6 Months | Count of Participants | Participants |
|
| 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 | Overall Survival | Posted | Median | 95% Confidence Interval | months | From date of registration to maximum of 3 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Posted | Median | 95% Confidence Interval | months | From date of registration to maximum of 3 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease | Images for response assessed by the central computer-assisted image-analysis system were never collected. | Posted | Count of Participants | Participants | From date of registration to maximum of 3 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Frequency and Severity of Toxicities | Number of Subjects With Greater Than Grade 2 Toxicity | Posted | Number | participants | From date of registration to maximum of 3 years |
|
|
|
From date of registration to maximum of 3 years.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
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 | Erlotinib and Bevacizumab | Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. | 56 | 79 | 6 | 79 | 77 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricular diastolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ulcer, GI - Stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Carbon monoxide diffusion capacity (DL(co)) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Carbon monoxide diffusion capacity (DL(co)) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symp) - Oral cav | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Laboratory-Other | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, not d/t neuropathy - body/general | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory - Nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss/Alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lung Committee Statistician | SWOG Statistical Center | 206-667-6197 | jmoon@fhcrc.org |
| Mar 20, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| 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 |
| D000069347 | Erlotinib Hydrochloride |
| 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 |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 |
|
| Never |
|
| 10-20% |
|
| Unknown |
|
|
| Title | Denominators | Categories | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
| Categories |
|---|
| AST, SGOT |
| |||||
| Albumin, serum-low (hypoalbuminemia) |
| |||||
| Anorexia |
| |||||
| Ataxia (incoordination) |
| |||||
| CNS cerebrovascular ischemia |
| |||||
| Carbon monoxide diffusion capacity (DL(co)) |
| |||||
| Creatinine |
| |||||
| Dehydration |
| |||||
| Diarrhea |
| |||||
| Dry skin |
| |||||
| Dyspnea (shortness of breath) |
| |||||
| Extremity-lower (gait/walking) |
| |||||
| Fatigue (asthenia, lethargy, malaise) |
| |||||
| Hypertension |
| |||||
| Hypoxia |
| |||||
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung |
| |||||
| Left ventricular diastolic dysfunction |
| |||||
| Left ventricular systolic dysfunction |
| |||||
| Mucositis/stomatitis (clinical exam) - Oral cavity |
| |||||
| Mucositis/stomatitis (functional/symp) - Oral cav |
| |||||
| Muscle weakness, not d/t neuropathy - body/general |
| |||||
| Nail changes |
| |||||
| Nausea |
| |||||
| Ocular/Visual-Other (Specify) |
| |||||
| Pain - Chest wall |
| |||||
| Pain - Extremity-limb |
| |||||
| Pain - Head/headache |
| |||||
| Potassium, serum-high (hyperkalemia) |
| |||||
| Potassium, serum-low (hypokalemia) |
| |||||
| Proteinuria |
| |||||
| Pruritus/itching |
| |||||
| Pulmonary/Upper Respiratory-Other (Specify) |
| |||||
| Rash/desquamation |
| |||||
| Rash: acne/acneiform |
| |||||
| Rash: hand-foot skin reaction |
| |||||
| Renal failure |
| |||||
| Renal/Genitourinary-Other (Specify) |
| |||||
| Retinal detachment |
| |||||
| Sodium, serum-low (hyponatremia) |
| |||||
| Speech impairment (e.g., dysphasia or aphasia) |
| |||||
| Syncope (fainting) |
| |||||
| Ulcer, GI - Duodenum |
| |||||
| Ulcer, GI - Stomach |
| |||||
| Ulceration |
| |||||
| Vomiting |
| |||||
| Weight loss |
| |||||
| Wound complication, non-infectious |
|