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Sponsored by: |
Royal Marsden NHS Foundation Trust |
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Information provided by: | Royal Marsden NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00220168 |
The objective of this study is to assess the efficacy and toxicity of a 3 weekly regimen containing irinotecan combined with capecitabine in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma or squamous cell carcinoma originating from the oesophagus, oesophagogastric junction or stomach who have previously received chemotherapy and have either failed to respond or who have relapsed within 3 months after an initial response will be eligible for treatment in this study.
The response rate, failure-free survival and overall survival of treated patients 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, Capecitabine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours |
Estimated Enrollment: | 33 |
Study Start Date: | January 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Surrey | |
Royal Marsden Hospital | |
Sutton, Surrey, United Kingdom, SM2 5PT |
Principal Investigator: | David Cunningham | Royal Marsden NHS Foundation Trust |
Study ID Numbers: | 2166 |
Study First Received: | September 19, 2005 |
Last Updated: | October 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00220168 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Antimetabolites Capecitabine Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Irinotecan Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Irinotecan |
Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |