Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer
- Evaluate the response rate in patients with previously untreated metastatic colorectal
cancer treated with capecitabine, oxaliplatin, and bevacizumab.
- Assess time to progression (TTP), disease-free survival (DFS), and overall survival
(OS) in patients treated with this regimen.
- Assess the safety and tolerability of bevacizumab, oxaliplatin, and capecitabine in
patients with previously untreated metastatic colorectal cancer.
- Evaluate the effect of this regimen on the biomarkers of angiogenesis.
- Assess the effect of this regimen on wound angiogenesis.
OUTLINE: Patients receive oral capecitabine twice daily on days 1-5 and 8-12, oxaliplatin IV
over 2 hours on day 1, and bevacizumab IV over 1-1½ hours on day 1. Courses repeat every 14
days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (Percentage of Participants With Partial or Complete Response)
Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression. Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. The definitions were: Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.
Herbert I. Hurwitz, MD
Duke Cancer Institute
United States: Food and Drug Administration