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

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00205322

Purpose

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 II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Capecitabine Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Oxaliplatin, 5-Fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer

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

Secondary Outcome Measures:

is the oral drug an advantage in this patient population

Estimated 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)

Eligibility

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

Criteria

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

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Daniel Mulkerin, MD

University of Wisconsin, Madison

More Information

Responsible Party:	UWCCC ( Dan Mulkerin )
Study ID Numbers:	M-2003-0544
Study First Received:	September 13, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00205322
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Vitamin B Complex
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009