Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Camptothecin; Capecitabine; Irinotecan

Criteria

Inclusion Criteria:

• Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma

• Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)

• Eastern Cooperative Oncology Group performance status of ?2

Exclusion Criteria:

• Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh Classification

• Current history of chronic diarrhoea

• Reproductive potential not using adequate contraceptive measures