A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma
Phase 2
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Both
Carcinoma, Hepatocellular
Both
Carcinoma, Hepatocellular
Trial Information
A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate
Outcome Time Frame:
Week 6
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Korea: Independent Review Committee
Study ID:
XRP4174/2501
NCT ID:
NCT00635323
Start Date:
November 2002
Completion Date:
May 2005
Related Keywords:
- Carcinoma, Hepatocellular
- Carcinoma
- Carcinoma, Hepatocellular
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