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Sponsored by: |
Hokkaido Gastrointestinal Cancer Study Group |
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Information provided by: | Hokkaido Gastrointestinal Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00209625 |
We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: irinotecan Drug: leucovorin Drug: fluorouracil |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer:Hokkaido Gastrointestinal Cancer Study Group:HGCSG0001 |
Estimated Enrollment: | 23 |
Study Start Date: | April 2000 |
Estimated Study Completion Date: | November 2004 |
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan, leucovorin plus fluorouracil. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), median survival time (MST), incidence and severity of adverse event.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Hokkaido | |
Hokkaido University Hospital | |
Sapporo, Hokkaido, Japan, 060-8638 |
Study Chair: | Masahiro Asaka, MD, PhD | Hokkaido Gastrointestinal Cancer Study Group |
Study ID Numbers: | HGCSG0001 |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00209625 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Irinotecan, leucovorin, fluorouracil, PhaseI/II, colorectal cancer, |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Fluorouracil Irinotecan Colonic Diseases |
Leucovorin Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Antineoplastic Agents, Phytogenic |