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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 Identifier:
First received: October 24, 2002
Last updated: November 1, 2016
Last verified: November 2016
This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous 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: Irinotecan Drug: capecitabine [Xeloda] Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of the Effect of Continuous Xeloda Therapy 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 measurements (RECIST criteria) [ Time Frame: Event driven ]

Secondary Outcome Measures:
  • Time to progression, time to response, duration of response, time to treatment failure, survival.\n [ Time Frame: Event driven ]

Enrollment: 57
Study Start Date: July 2001
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Irinotecan
100mg/m2 iv on days 1, 8, 15 and 22 of each 6 week cycle.
Drug: capecitabine [Xeloda]
1000mg po bid


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 identifier: NCT00048126

United States, Alabama
Hoover, Alabama, United States, 35216
United States, California
La Jolla, California, United States, 92037-1030
United States, Florida
Miami, Florida, United States, 33176
United States, Massachusetts
Boston, Massachusetts, United States, 02120
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
United States, New York
New York, New York, United States, 10028
United States, North Carolina
Charlotte, North Carolina, United States, 28233-3549
United States, Rhode Island
Providence, Rhode Island, United States, 02908
United States, Tennessee
Memphis, Tennessee, United States, 38120
Nashville, Tennessee, United States, 37203-1632
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00048126     History of Changes
Other Study ID Numbers: MO16460
Study First Received: October 24, 2002
Last Updated: November 1, 2016

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
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on September 21, 2017