A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00069108

Purpose

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. 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) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 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 Irinotecan Irinotecan hydrochloride Capecitabine Fluorouracil Oxaliplatin

U.S. FDA Resources

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 Versus iv Fluorouracil/Leucovorin, Both in Combination With Eloxatin, on Tumor Progression in Patients With Metastatic Colorectal Cancer Who Received Prior CPT-11 and 5-Fluorouracil/Leucovorin

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Time to tumor progression [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival, overall response rate, time to response, duration of response, time to treatment failure. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory outcomes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	627
Study Completion Date:	January 2008

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 1000mg/m2 po 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;
metastatic colorectal cancer;
>=1 target lesion;
failed first-line chemotherapy with 5-fluorouracil and irinotecan.

Exclusion Criteria:

previous treatment with oxaliplatin;
progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
>=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069108

Show 109 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:	NO16967
Study First Received:	September 15, 2003
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00069108
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Disease Progression
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