A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer - Full Text View

Purpose

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine [Xeloda] Drug: Oxaliplatin 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 Oxaliplatin

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 of the Effect of Intermittent Xeloda in Combination With Eloxatin, Versus Fluorouracil/Leucovorin, on Disease-Free Survival in Patients Who Have Undergone Surgery for Colon Cancer.2

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Superiority in disease-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	1886
Study Start Date:	April 2003
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 1000mg/m2 iv bid on days 1-15 of each 3 week cycle Drug: Oxaliplatin As prescribed, in 3 week cycles
2: Active Comparator	Drug: Oxaliplatin As prescribed, in 2 week cycles Drug: Leucovorin As prescribed, in 2 week cycles. Drug: 5 FU As prescribed, in 2 week cycles

Eligibility

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

Criteria

Inclusion Criteria:

adult patients >=18 years of age;
colon cancer;
complete tumor resection.

Exclusion Criteria:

prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the currently treated colon cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069121

Show 228 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:	NO16968
First Received:	September 15, 2003
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00069121
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

Oxaliplatin

Digestive System Diseases

Fluorouracil

Gastrointestinal Neoplasms

Colonic 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 November 20, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00069121