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: October 1, 2015
Last verified: October 2015
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: 5 FU
Drug: Leucovorin
Drug: Oxaliplatin
Drug: capecitabine [Xeloda]
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: Oxaliplatin
As prescribed, in 3 week cycles
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-15 of each 3 week cycle
Active Comparator: 2 Drug: 5 FU
As prescribed, in 2 week cycles
Drug: Leucovorin
As prescribed, in 2 week cycles
Drug: Oxaliplatin
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
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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: October 1, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016