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| Sponsor: | Royal Marsden NHS Foundation Trust |
|---|---|
| Information provided by: | Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00220168 |
Purpose
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 |
|---|---|---|
|
Upper Gastrointestinal Tumours |
Drug: Irinotecan, Capecitabine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours |
| Enrollment: | 33 |
| Study Start Date: | January 2003 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| Royal Marsden Hospital | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Principal Investigator: | David Cunningham | Royal Marsden NHS Foundation Trust |
More Information
| Responsible Party: | Jane Lawrence, Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00220168 History of Changes |
| Other Study ID Numbers: | 2166 |
| Study First Received: | September 19, 2005 |
| Last Updated: | December 15, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Digestive System Neoplasms Gastrointestinal Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Irinotecan Capecitabine Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |