A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours
- 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
- Medical or psychiatric conditions resulting in inability of patient to give written
- 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).
- Previous malignancy other than adequately treated basal cell carcinoma of the skin or
cervical carcinoma in situ.