Oxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00205322

CO03216

SMPH/MEDICINE/H (Other Identifier)

M-2003-0544 (Other Identifier)

A534260 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)