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

Phase 4
18 Years
Not Enrolling
Upper Gastrointestinal Tumours

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Response rates

Principal Investigator

David Cunningham

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Upper Gastrointestinal Tumours
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms