A Phase II Trial Evaluating Irinotecan Plus 5FU/LV in Patients With Relapsed/Refractory Upper GI Tumours

Inclusion Criteria: Histologically proven adenocarcinoma or squamous cell carcinoma of the Oesophagus, O-G junction, stomach and pancreas, not amenable to surgical resection. Bidimensionally measurable disease, or unidimensional measurable disease accessible 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 at least 4 weeks 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, serum creatinine 135 mol/litre 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 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.