A Phase II Trial Evaluating Irinotecan Plus 5FU/LV in Patients With Relapsed/Refractory Upper GI Tumours
Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
Participant gender:
Summary
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.