Phase II Study of Oxaliplatin, Capecitabine, Cetuximab, and Bevacizumab in the Treatment of Metastatic Colorectal Cancer
- Determine the response rate in patients with unresectable metastatic or recurrent
colorectal adenocarcinoma treated with capecitabine, cetuximab, oxaliplatin, and
- Determine the safety and tolerability of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this
- Determine the effect of this regimen on the angiogenesis biomarkers in these patients.
- Determine the effect of this regimen on wound angiogenesis in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Patients will also receive
cetuximab IV over 1-2 hours, oxaliplatin IV over 2 hours, and bevacizumab IV over 30-90
minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or
After completion of study treatment, patients are followed for 1 month.
PROJECTED ACCRUAL: Approximately 45 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
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|