Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer
This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. This study is being done to find out how long it takes tumors to grow after patients receive the drugs capecitabine, oxaliplatin and bevacizumab. Capecitabine (also called Xeloda) is a drug that has been approved by the FDA for treatment of advanced colorectal cancer. Capecitabine prevents some colorectal cancer cancer cells from reproducing, and causes some of them to die. Oxaliplatin (also called Eloxatin) has also been approved by the FDA for treatment of advanced colorectal cancer. Oxaliplatin prevents some colorectal cancer cells from reproducing. Bevacizumab is an investigational drug. Bevacizumab is an antibody (a protein that acts against a specific substance) directed against vascular endothelial growth factor (VEGF). VEGF promotes the growth of blood vessels that bring nutrients to cells. Bevacizumab inhibits the growth of colon cancer cells, by blocking the effects of VEGF. The combination of the drugs used in this study is experimental. The purpose of this study is to see how long it takes patients' tumors to grow when they are taking this combination of drugs.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer|
- Median Time for Progression Free Survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.
- Number of Participants With Grade 3 or Higher Toxicity [ Time Frame: Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months. ] [ Designated as safety issue: Yes ]Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom.
|Study Start Date:||February 2005|
|Study Completion Date:||March 2013|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Oxaliplatin, followed by Bevacizumab with Capecitabine
oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Other Name: EloxatinDrug: Bevacizumab
Other Name: AvastinDrug: Capecitabine
Other Name: Xeloda
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159432
|United States, California|
|U.S.C./Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Syma Iqbal, M.D.||U.S.C. Norris Comprehensive Cancer Center|