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

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-12
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-19

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