S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Unspecified
Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:
- Selected stage IIIB disease (T4 [secondary to malignant pleural effusion only], any N, M0)
- Stage IV disease (any T, any N, M1 [distant metastases present])
Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan
- The CT scan from a combined PET/CT scan may only be used to document nonmeasurable disease
- Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
- Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
No untreated brain metastases
- Patients with treated brain metastases are allowed provided metastases have remained controlled for at least two weeks following treatment, AND patient has no residual neurological dysfunction off corticosteroids
- Patients with neurologic abnormalities on physical examination or symptoms must have a negative pretreatment CT or MRI scan of the brain 28 days prior to registration
PATIENT CHARACTERISTICS:
- Zubrod performance status 2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 1,000/mm³
- Serum bilirubin normal
- SGOT or SGPT normal
- Serum creatinine ≤ 2 times upper limit of normal OR creatinine clearance ≥ 50 mL/min
- Willing to provide prior smoking history as requested on the prestudy form
- No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
- No malabsorption syndrome or requirement for IV alimentation
- No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
No significant history of cardiac disease, including any of the following:
- Uncontrolled high blood pressure
- Unstable angina
- Congestive heart failure
- Myocardial infarction within the past 6 months
- Cardiac ventricular arrhythmia requiring medication
- No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery) and recovered
- At least 1 year since prior adjuvant chemotherapy
- No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced NSCLC
- No prior EGFR inhibitors
- No prior surgical procedures affecting absorption
- No concurrent major surgery
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Kaiser Permanente - Deer Valley
- Alta Bates Summit Comprehensive Cancer Center
- Peninsula Medical Center
- Kaiser Permanente - Fremont
- Kaiser Permanente Medical Center - Hayward
- USC/Norris Comprehensive Cancer Center and Hospital
- Contra Costa Regional Medical Center
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
- El Camino Hospital Cancer Center
- Sutter Health - Western Division Cancer Research Group
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- CCOP - Bay Area Tumor Institute
- Kaiser Permanente Medical Center - Oakland
- Epic Care - Oakland
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Kaiser Permanente Medical Center - Redwood City
- Kaiser Permanente Medical Center - Richmond
- Kaiser Permanente Medical Center - Roseville
- University of California Davis Cancer Center
- South Sacramento Kaiser-Permanente Medical Center
- Kaiser Permanente Medical Center - Sacramento
- Kaiser Permanente Medical Center - San Francisco Geary Campus
- California Pacific Medical Center - California Campus
- Kaiser Permanente Medical Center - Santa Teresa
- Doctors Medical Center - San Pablo Campus
- Kaiser Foundation Hospital - San Rafael
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
- Kaiser Permanente Medical Center - Santa Rosa
- Kaiser Permanente Medical Center - South San Francisco
- Kaiser Permanente Medical Facility - Stockton
- Tahoe Forest Cancer Center
- Kaiser Permanente Medical Center - Vacaville
- Kaiser Permanente Medical Center - Vallejo
- Sutter Solano Medical Center
- Kaiser Permanente Medical Center - Walnut Creek
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Kaiser Permanente - Moanalua Medical Center and Clinic
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute
- Mountain States Tumor Institute at St. Luke's
- Decatur Memorial Hospital Cancer Care Institute
- Regional Cancer Center at Memorial Medical Center
- St. Rose Ambulatory and Surgery Center
- Hays Medical Center
- Hutchinson Hospital Corporation
- Kansas City Cancer Centers - West
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Kansas City Cancer Centers - Southwest
- Mount Carmel Regional Cancer Center
- Tammy Walker Cancer Center at Salina Regional Health Center
- Kansas City Cancer Center - Shawnee Mission
- St. Francis Comprehensive Cancer Center
- Veterans Affairs Medical Center - Topeka (O'Neil)
- Cancer Center of Kansas, PA - Winfield
- Lahey Clinic Medical Center - Burlington
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- St. John Macomb Hospital
- Regional Cancer Center at Singing River Hospital
- Truman Medical Center - Hospital Hill
- Veterans Affairs Medical Center - Kansas City
- Kansas City Cancer Centers - South
- Kansas City Cancer Centers - North
- Kansas City Cancer Centers - East
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Randolph Hospital
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Harrington Cancer Center
- Huntsman Cancer Institute at University of Utah
- Danville Regional Medical Center
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- Island Hospital Cancer Care Center at Island Hospital
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Highline Medical Center Cancer Center
- Swedish Medical Center - Issaquah Campus
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Harrison Poulsbo Hematology and Onocology
- Harborview Medical Center
- Minor and James Medical, PLLC
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology, PS
- Wenatchee Valley Medical Center
- Rocky Mountain Oncology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm I
Arm II
Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.