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

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: December 2, 2011
Last verified: December 2011

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.

Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Is the oral drug an advantage in this patient population [ Time Frame: Bi-monthly collection of information regarding tumor progression and overall survival ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: April 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205322

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Daniel Mulkerin, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205322     History of Changes
Other Study ID Numbers: M-2003-0544 (CO03216)
Study First Received: September 13, 2005
Last Updated: December 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014