- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00220168
Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours
A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- Royal Marsden Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 <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
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Response rates
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Time to disease progression (TTP)
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Secondary Outcome Measures
Outcome Measure |
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Quality of life
|
Survival
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Toxicity (incidence of febrile neutropenia, in-patient admissions, severity of diarrhea, mucositis, aesthesia, transfusion requirements).
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Collaborators and Investigators
Investigators
- Principal Investigator: David Cunningham, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Capecitabine
- Irinotecan
Other Study ID Numbers
- 2166
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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