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Sponsors and Collaborators: |
Royal Marsden NHS Foundation Trust Aventis Pharmaceuticals |
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Information provided by: | Royal Marsden NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00220064 |
The objective of this study is to assess the efficacy and toxicity of a 2 weekly regimen containing irinotecan combined with leucovorin-modified 5-fluorouracil in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma originating from the oesophagogastric junction, stomach or pancreas who have previously received chemotherapy and have either failed to respond or who have relapsed after an initial response will be eligible for treatment in this study.
The response rate, failure-free survival and overall survival of treated patients with the two different regimes will be evaluated. Toxicity and quality of life will also be monitored closely.
Condition | Intervention | Phase |
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Upper Gastrointestinal Tumours |
Drug: Irinotecan, 5-Fluorouracil, Leucovorin |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial Evaluating Irinotecan With 5_fluorouracil Plus Leucovorin in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 1810 |
Study First Received: | September 19, 2005 |
Last Updated: | October 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00220064 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Antimetabolites Digestive System Neoplasms Vitamin B Complex Immunologic Factors Gastrointestinal Diseases Irinotecan Leucovorin Trace Elements |
Immunosuppressive Agents Digestive System Diseases Fluorouracil Vitamins Gastrointestinal Neoplasms Micronutrients Antineoplastic Agents, Phytogenic |
Antimetabolites Vitamin B Complex Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Irinotecan Leucovorin |
Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Vitamins Therapeutic Uses Fluorouracil Gastrointestinal Neoplasms Micronutrients Antineoplastic Agents, Phytogenic |