Non-Small Cell Lung Cancer Clinical Trial
Official title:
Phase II Trial OF Oxaliplatin and Gemcitabine With Bevacizumab in Advanced Non-Small Cell Lung Cancer
Verified date | May 2008 |
Source | Mt. Sinai Medical Center, Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The combination of oxaliplatin and gemcitabine has proven activity in advanced non-small cell lung cancer (NSCLC). Due to its favorable toxicity profile, this combination is optimal for adding new agents. Bevacizumab is an anti-VEGF monoclonal antibody that has also shown favorable results in advanced NSCLC. This study will add bevacizumab to oxaliplatin and gemcitabine as first line treatment in patients with Stage IIIB and IV NSCLC.
Status | Completed |
Enrollment | 45 |
Est. completion date | March 2008 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Confirmed non-small cell lung cancer, EXCEPT squamous cell cancer - Stage IIIB or IV disease - ECOG PS 0-1 - No prior treatment - No brain metastases - Must have measurable disease Exclusion Criteria: - Deep vein thromboses or pulmonary embolus within 1 year - History of gross hemoptysis |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Medical Center | Miami Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Mt. Sinai Medical Center, Miami | Genentech, Inc., Sanofi-Synthelabo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the overall time to progression of the combination regimen of Gemcitabine, Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer. | Prospective | Yes | |
Secondary | • To determine the overall response rate • To determine the overall survival. • To determine the toxicity of Gemcitabine, Oxaliplatin given in combination with Bevacizumab | Prospective | Yes |
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