A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 89
- Locations
- 152
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
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 also may stop the growth of non-small cell lung cancer 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 IIIB or stage IV primary non-small cell lung cancer who have never smoked.
Detailed Description
OBJECTIVES:
Primary
- Assess overall survival of patients with stage IIIB or IV primary non-small cell lung adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and bevacizumab.
Secondary
- Assess progression-free survival of patients treated with this regimen.
- Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset of patients with measurable disease treated with this regimen.
- Evaluate the frequency and severity of toxicities associated with this regimen in these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Erlotinib and Bevacizumab
Intervention: bevacizumab (Biological)
Erlotinib and Bevacizumab
Intervention: erlotinib hydrochloride (Drug)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Secondary Outcomes
- Response Rate (Complete and Partial)(Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.)
- Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs(Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.)
- Progression-free Survival(Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.)