Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study was to evaluate the feasibility of TS determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-FU treatment in MCRC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ulm
• Collaborators: Medac, Hamburg, Germany; Pfizer, Berlin Germany; Study Group Oncology of Gastrointestinal Tumors (FOGT)

Criteria

Inclusion Criteria:

• patients (>= 18 years) with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy

• a performance status WHO 0-2 (Karnofsky >= 60%)

• an estimated life expectancy of at least 3 months

• written informed consent

Exclusion Criteria:

• patients older than 75 years not fulfilling these criteria

• brain metastases or a secondary cane

• a history of a systemic palliative chemotherapy

• and an adjuvant chemotherapy (within 6 months)

• pregnant or nursing women

• a known allergy toward irinotecanhydroclorid or of any ingredients of Campto or other severe medical

• laboratory and social conditions not allowing chemotherapy and follow-up