Oxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer
Phase 2
Completed
- Conditions
- Metastatic Colorectal Cancer
- Registration Number
- NCT00205322
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both patient convenience and lack of associated catheter-related complications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- no prior treatment for metastatic disease
- PS 0-2
- measurable disease
Exclusion Criteria
- neuropathy > or equal to grade 2
- concomitant radiation therapy or other systemic cancer therapies
- brain mets
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients Bi-monthly collection of information regarding tumor progression and overall survival.
- Secondary Outcome Measures
Name Time Method Is the oral drug an advantage in this patient population Bi-monthly collection of information regarding tumor progression and overall survival
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of Wisconsin🇺🇸Madison, Wisconsin, United States