S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma
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.
Drug: erlotinib hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)|
- Overall Survival [ Time Frame: From date of registration to maximum of 3 years ] [ Designated as safety issue: No ]
- Progression-free Survival [ Time Frame: From date of registration to maximum of 3 years ] [ Designated as safety issue: No ]
- Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease [ Time Frame: From date of registration to maximum of 3 years ] [ Designated as safety issue: No ]Images for response assessed by the central computer-assisted image-analysis system were never collected.
- Toxicity [ Time Frame: From date of registration to maximum of 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
|Experimental: Erlotinib and Bevacizumab||Biological: bevacizumab Drug: erlotinib hydrochloride|
- Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib hydrochloride and bevacizumab.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436332
Show 148 Study Locations
|Study Chair:||Howard L. West, MD||Swedish Cancer Institute at Swedish Medical Center - First Hill Campus|