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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00445848 |
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 | Intervention | Phase |
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Lung Cancer |
Biological: bevacizumab Drug: erlotinib hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, 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 |
Estimated Enrollment: | 80 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Adenocarcinoma
Stage IIIB or IV disease as defined below:
Selected stage IIIB disease
Stage IV disease
Measurable and/or nonmeasurable disease by CT scan, positron emission tomography scan, or MRI
PATIENT CHARACTERISTICS:
No other prior malignancy except for the following:
PRIOR CONCURRENT THERAPY:
Study Chair: | Howard L. West, MD | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus |
Investigator: | Antoinette J. Wozniak, MD | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
Study ID Numbers: | CDR0000531056, SWOG-S0636 |
Study First Received: | March 7, 2007 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00445848 History of Changes |
Health Authority: | Unspecified |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
Thoracic Neoplasms Erlotinib Bevacizumab Protein Kinase Inhibitors Angiogenesis Inhibitors Carcinoma Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Bevacizumab Protein Kinase Inhibitors Angiogenesis Inhibitors |
Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Growth Inhibitors Angiogenesis Modulating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |