Status:
COMPLETED
Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2005
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00635323
Start Date
November 1 2002
End Date
May 1 2005
Last Update
April 7 2008
Active Locations (9)
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1
Pfizer Investigational Site
Shanghai, China, 200433
2
Pfizer Investigational Site
Hong Kong SAR, Hong Kong
3
Pfizer Investigational Site
Seoul, South Korea, 135-710
4
Pfizer Investigational Site
Seoul, South Korea, 136-705