S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00445848|
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : September 7, 2016
Last Update Posted : March 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: bevacizumab Drug: erlotinib hydrochloride||Phase 2|
- 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.
- 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.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride 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 periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||January 2014|
|Experimental: Erlotinib and Bevacizumab||
Drug: erlotinib hydrochloride
- 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.
- Progression-free 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 first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0), as a 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, or unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided) or appearance of any new lesion/site, or death due to disease without prior documentation of progression and without symptomatic deterioration.
- Response Rate (Complete and Partial) [ 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. ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
All target measurable lesions must be assessed using the same techniques as baseline.
- Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs [ Time Frame: Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy. ]Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445848
|Study Chair:||Howard L. West, MD||Swedish Cancer Institute at Swedish Medical Center - First Hill Campus|