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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00425646 |
RATIONALE: Imatinib mesylate 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. Imatinib mesylate and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving imatinib mesylate together with bevacizumab as maintenance therapy may stop non-small cell lung cancer from growing or coming back.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with bevacizumab after first-line chemotherapy and bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: bevacizumab Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Evaluating a Maintenance Strategy of Gleevce® (Imatinib Mesylate) and Bevacizumab in Patients With Advanced, Non-Squamous, Non-Small Cell Lung Cancer, Following Completion of First-Line Chemotherapy With Bevacizumab |
Estimated Enrollment: | 50 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate twice daily on days 1-21 and bevacizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 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
No predominately squamous cell carcinoma
Must have completed 4 courses of platinum-based, doublet chemotherapy and bevacizumab*, has no disease progression, and meets the following criteria:
A change in the platinum doublet is acceptable provided the following are true:
PATIENT CHARACTERISTICS:
No medical comorbidities, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy in the metastatic setting, except for 4 courses of platinum-based, doublet chemotherapy plus bevacizumab in the first-line setting
No concurrent therapeutic coagulation comprising warfarin, heparin, or low molecular weight heparin
United States, Washington | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109-1023 |
Study Chair: | Laurie Carr, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium ( Laurie Carr ) |
Study ID Numbers: | CDR0000526130, UWCC-6351, UWCC-06-3622-H/B, NOVARTIS-UWCC-6351 |
Study First Received: | January 19, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00425646 |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
bronchoalveolar cell lung cancer large cell lung cancer recurrent non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma, Bronchiolo-Alveolar Bevacizumab Recurrence Carcinoma Imatinib |
Adenocarcinoma of lung Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |