Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours
This study has been completed.
Sponsor:
Royal Marsden NHS Foundation Trust
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220168
First received: September 19, 2005
Last updated: December 15, 2009
Last verified: December 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Upper Gastrointestinal Tumours |
Drug: Irinotecan, Capecitabine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours |
Resource links provided by NLM:
Further study details as provided by Royal Marsden NHS Foundation Trust:
Primary Outcome Measures:
- Response rates
- Time to disease progression (TTP)
Secondary Outcome Measures:
- Survival
- Quality of life
- Toxicity (incidence of febrile neutropenia, in-patient admissions, severity of diarrhea, mucositis, aesthesia, transfusion requirements).
| Enrollment: | 33 |
| Study Start Date: | January 2003 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 <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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220168
Locations
| United Kingdom | |
| Royal Marsden Hospital | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
| Principal Investigator: | David Cunningham | Royal Marsden NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Jane Lawrence, Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00220168 History of Changes |
| Other Study ID Numbers: | 2166 |
| Study First Received: | September 19, 2005 |
| Last Updated: | December 15, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Digestive System Neoplasms Gastrointestinal Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Irinotecan Capecitabine Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013