A Phase II Trial Evaluating Irinotecan Plus 5FU/LV in Patients With Relapsed/Refractory Upper GI Tumours
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|ClinicalTrials.gov Identifier: NCT00220064|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 31, 2013
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 or disease||Intervention/treatment||Phase|
|Upper Gastrointestinal Tumours||Drug: Irinotecan, 5-Fluorouracil, Leucovorin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Evaluating Irinotecan With 5_fluorouracil Plus Leucovorin in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours|
|Study Start Date :||July 2000|
|Actual Study Completion Date :||November 2005|
- Disease stabilization rate or tumour marker response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220064
|Principal Investigator:||David Cunningham||Royal Marsden NHS Foundation Trust|