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Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00048126 |
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: capecitabine [Xeloda] Drug: Irinotecan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 57 |
Study Completion Date: | January 2005 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: capecitabine [Xeloda]
1000mg po bid
Drug: Irinotecan
100mg/m2 iv on days 1, 8, 15 and 22 of each 6 week cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
NASHVILLE, Tennessee, United States, 37203-1632 | |
MEMPHIS, Tennessee, United States, 38120 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | MO16460 |
Study First Received: | October 24, 2002 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00048126 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases |
Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |