Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 19, 2005

Last Updated Date

October 10, 2006

Start Date ^†

January 2003

Current Primary Outcome Measures ^†

Response rates
Time to disease progression (TTP)

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00220168 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Upper Gastrointestinal Tumours

Intervention ^†

Drug: Irinotecan, Capecitabine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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 <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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00220168

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Royal Marsden NHS Foundation Trust

Collaborators ^††

Investigators ^†

Principal Investigator:

David Cunningham

Royal Marsden NHS Foundation Trust

Information Provided By

Royal Marsden NHS Foundation Trust

Verification Date

September 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.