Status:
COMPLETED
A Phase II Trial Evaluating Irinotecan Plus 5FU/LV in Patients With Relapsed/Refractory Upper GI Tumours
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Upper Gastrointestinal Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to assess the efficacy and toxicity of a 2 weekly regimen containing irinotecan combined with leucovorin-modified 5-fluorouracil in the setting of relapsed or refractory...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00220064
Start Date
July 1 2000
End Date
November 1 2005
Last Update
May 31 2013
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