Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours
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.
|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|
- Response rates
- Time to disease progression (TTP)
- Quality of life
- Toxicity (incidence of febrile neutropenia, in-patient admissions, severity of diarrhea, mucositis, aesthesia, transfusion requirements).
|Study Start Date:||January 2003|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220168
|Royal Marsden Hospital|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Principal Investigator:||David Cunningham||Royal Marsden NHS Foundation Trust|