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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048126
Recruitment Status : Completed
First Posted : October 25, 2002
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: Irinotecan Drug: capecitabine [Xeloda] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
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
Study Start Date : July 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Tumor measurements (RECIST criteria) [ Time Frame: Event driven ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048126

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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
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT00048126    
Other Study ID Numbers: MO16460
First Posted: October 25, 2002    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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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
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors