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

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

MedlinePlus related topics:

Cancer Colorectal Cancer

Drug Information available for:

Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Capecitabine Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, 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

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 132 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	M66001
First Received:	February 2, 2001
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00009737
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Capecitabine

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Leucovorin

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Digestive System Diseases

Fluorouracil

Gastrointestinal Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Vitamin B Complex

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Vitamins

Micronutrients

ClinicalTrials.gov processed this record on November 20, 2008

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