A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: September 15, 2003
Last updated: April 7, 2014
Last verified: April 2014

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

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 Start Date: May 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-15 of each 3 week cycle
Drug: Oxaliplatin
As prescribed, in 3 week cycles
Active Comparator: 2 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


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

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 116 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00069108     History of Changes
Other Study ID Numbers: NO16967
Study First Received: September 15, 2003
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014