Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours

Conditions
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Upper Gastrointestinal Tumours

Intervention / Treatment
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* Drug: Irinotecan, Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven adenocarcinoma or squamous cell carcinoma of oesophagus, O-G junction and stomach, not amenable to surgical resection. Bidimensionally measurable disease, or unidimensional measurable disease assessable by CT scanning, not within previously irradiated areas. Patients with progressive disease during previous chemotherapy treatment or within three months of stopping treatment. At least one previous chemotherapy regimen, given within 3 months prior to inclusion in this study. No previous exposure to irinotecan. Adequate bone marrow function with platelets >100 X 109/L; WBC > 3 X 109/L; Neutrophils > 1.5 X 109/L at the time of study entry. Satisfactory renal function. Creatinine clearance (measured by Cockcroft and Gault) >50ml/min and Cr <135. Satisfactory liver function: In the absence of liver metastases: Bilirubin < 1.25N (N=upper limit of normal range) Hepatic transaminases < 2.5N Prothrombin time < 1.5N In the presence of liver metastases: Bilirubin < 1.5N Hepatic transaminases < 5N Prothrombin time < 1.5N No uncontrolled medical condition No previous malignant disease except for non-melanotic skin cancer or in-situ carcinoma of the uterine cervix. ECOG performance status of 0, 1 or 2. Predicted life expectancy of > 3 months. Adequate contraceptive precautions Informed written consent Exclusion Criteria: Medical or psychiatric conditions resulting in inability of patient to give written consent. ECOG Performance status >2 Intracerebral metastases or meningeal carcinomatosis Unresolved bowel obstruction Creatinine clearance <50ml/min, Cr >135 Uncontrolled angina pectoris, heart failure (New York heart classification 3 or 4). Pregnancy/lactation Previous malignancy other than adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Irinotecan, Capecitabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rates |  |  | 
| Time to disease progression (TTP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 
| Quality of life |  |  | 
| Toxicity (incidence of febrile neutropenia, in-patient admissions, severity of diarrhea, mucositis, aesthesia, transfusion requirements). |  |  |