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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00220168
• Date of registration: 19/09/2005
• Prospective Registration: No
• Primary sponsor: Royal Marsden NHS Foundation Trust
• Public title: Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours
• Scientific title: A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours
• Date of first enrolment: January 2003
• Target sample size: 33
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00220168
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United Kingdom

Contacts

• Name: David Cunningham
• Affiliation: Royal Marsden NHS Foundation Trust

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Upper Gastrointestinal Tumours

Intervention(s)

Drug: Irinotecan, Capecitabine

Primary Outcome(s)

Time to disease progression (TTP)

Response rates

Secondary Outcome(s)

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

Survival

Quality of life

Secondary ID(s)

2166

Source(s) of Monetary Support

Please refer to primary and secondary sponsors