A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours

Royal Marsden NHS Foundation Trust1 site in 1 country33 target enrollmentJanuary 2003

ConditionsUpper Gastrointestinal Tumours

DrugsIrinotecan, Capecitabine

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Upper Gastrointestinal Tumours
Sponsor: Royal Marsden NHS Foundation Trust
Enrollment: 33
Locations: 1
Primary Endpoint: Response rates
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to assess the efficacy and toxicity of a 3 weekly regimen containing irinotecan combined with capecitabine in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma or squamous cell carcinoma originating from the oesophagus, oesophagogastric junction or stomach who have previously received chemotherapy and have either failed to respond or who have relapsed within 3 months after an initial response will be eligible for treatment in this study.

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

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

TBD

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Royal Marsden NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

•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 \<
•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
•Creatinine clearance \<50ml/min, Cr \>135
•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.

Outcomes

Primary Outcomes

Response rates

Time to disease progression (TTP)

Secondary Outcomes

Toxicity (incidence of febrile neutropenia, in-patient admissions, severity of diarrhea, mucositis, aesthesia, transfusion requirements).
Survival
Quality of life