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

Phase 2CompletedNCT00205322

University of Wisconsin, Madison45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Colorectal Cancer

Interventions

chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients

Time frame: Bi-monthly collection of information regarding tumor progression and overall survival.

Secondary Outcomes

Is the oral drug an advantage in this patient population

Time frame: Bi-monthly collection of information regarding tumor progression and overall survival

Data from ClinicalTrials.gov

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