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 * Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib hydrochloride and bevacizumab. Secondary * Determine the progression-free survival of patients treated with this regimen. * Compare, preliminarily, response as assessed by RECIST criteria vs response as assessed by a central computer-assisted image-analysis system in patients with measurable disease treated with this regimen. * Assess the frequency and severity of toxicities of this regimen in these patients. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Kaiser Permanente - Deer Valley
Antioch, California, United States
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Peninsula Medical Center
Burlingame, California, United States
Kaiser Permanente - Fremont
Fremont, California, United States
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States
Overall Survival
Time frame: From date of registration to maximum of 3 years
Progression-free Survival
Time frame: 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.
Time frame: From date of registration to maximum of 3 years
Frequency and Severity of Toxicities
Time frame: From date of registration to maximum of 3 years
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Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States
Valley Medical Oncology Consultants - Pleasanton
Pleasanton, California, United States
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States
...and 138 more locations