A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

This study has been completed.

First Received: February 2, 2001 Last Updated: May 13, 2009 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00009737

Purpose

This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-FU 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine [Xeloda] Drug: Leucovorin Drug: 5-FU	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label Study Comparing Adjuvant Chemotherapy With Xeloda, or 5-Fluorouracil Plus Leucovorin, on Disease-Free and Overall Survival in Patients Who Have Had Surgery for Colon Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

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

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Non-inferiority in disease-free survival, overall survival, and relapse-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AEs, laboratory parameters, QoL. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	3348
Study Completion Date:	March 2008

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 1250mg/m2 po bid on days 1-14 every 21 days.
2: Active Comparator	Drug: Leucovorin 20mg/m2 iv daily from day 1 to day 5 every 28 days. Drug: 5-FU 425mg/m2 iv daily from day 1 to day 5 every 28 days.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients 18-75 years of age;
histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.

Exclusion Criteria:

previous chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009737

Show 133 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	M66001
Study First Received:	February 2, 2001
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00009737 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Leucovorin
Rectal Diseases
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients

Capecitabine
Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009