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.