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

November 15, 2019 updated by: University of Wisconsin, Madison

A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer

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 Overview

Status

Completed

Conditions

Metastatic Colorectal Cancer

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Bi-monthly collection of information regarding tumor progression and overall survival.

Secondary Outcome Measures

Outcome Measure	Time Frame
Is the oral drug an advantage in this patient population Time Frame: Bi-monthly collection of information regarding tumor progression and overall survival	Bi-monthly collection of information regarding tumor progression and overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

Principal Investigator: Daniel Mulkerin, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

University of Wisconsin Carbone Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)