A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: October 24, 2002
Last updated: March 9, 2015
Last verified: March 2015

This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine [Xeloda]
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Tumor measurement (RECIST criteria) [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: October 2001
Study Completion Date: June 2005
Primary Completion Date: June 2005 (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: Irinotecan
250mg/m2 iv on day 1 of each 3 week cycle


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;
  • locally advanced and/or metastatic colorectal cancer;
  • >=1 target lesion.

Exclusion Criteria:

  • previous treatment with Xeloda or irinotecan;
  • previous systemic therapy for metastatic disease;
  • progressive disease during previous adjuvant therapy or within 6 months of completion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048139

United States, Arizona
Phoenix, Arizona, United States, 85012
United States, California
Fountain Valley, California, United States, 92708
La Jolla, California, United States, 92037-1030
Santa Rosa, California, United States, 95403
United States, Colorado
Denver, Colorado, United States, 80262
United States, Kansas
Hutchinson, Kansas, United States, 67502
United States, Nevada
Las Vegas, Nevada, United States, 89109
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Buffalo, New York, United States, 14263
United States, Texas
Houston, Texas, United States, 77030
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: NCT00048139     History of Changes
Other Study ID Numbers: MO16461
Study First Received: October 24, 2002
Last Updated: March 9, 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

ClinicalTrials.gov processed this record on March 25, 2015