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

Upper Gastrointestinal Tumours Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220168
• Other study ID #: 2166
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2005
• Last updated: December 15, 2009
• Start date: January 2003

Study information

• Verified date: December 2009
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Upper Gastrointestinal Tumours

Intervention

Drug:
• Irinotecan, Capecitabine

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rates
Primary	Time to disease progression (TTP)
Secondary	Survival
Secondary	Quality of life
Secondary	Toxicity (incidence of febrile neutropenia, in-patient admissions, severity of diarrhea, mucositis, aesthesia, transfusion requirements).