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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

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

U.S. FDA Resources

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:	May 1905
Estimated Study Completion Date:	December 2011

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 262 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	NO16968
Study First Received:	September 15, 2003
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00069121 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on November 27, 2009