A Phase II Trial Evaluating Irinotecan With 5_fluorouracil Plus Leucovorin in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours

Royal Marsden NHS Foundation Trust0 sites65 target enrollmentJuly 2000

ConditionsUpper Gastrointestinal Tumours

DrugsIrinotecan, 5-Fluorouracil, Leucovorin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Upper Gastrointestinal Tumours
Sponsor: Royal Marsden NHS Foundation Trust
Enrollment: 65
Primary Endpoint: Disease stabilization rate or tumour marker response
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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 upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma originating from the oesophagogastric junction, stomach or pancreas who have previously received chemotherapy and have either failed to respond or who have relapsed after an initial response will be eligible for treatment in this study.

The response rate, failure-free survival and overall survival of treated patients with the two different regimes will be evaluated. Toxicity and quality of life will also be monitored closely.

Registry

clinicaltrials.gov

Start Date

July 2000

End Date

November 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Royal Marsden NHS Foundation Trust

Responsible Party

Sponsor

Eligibility Criteria

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

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.