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

Sponsor
Pfizer
Study ID
NCT00635323
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan plus capecitabine — DRUG
    Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for

Study Details

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

Key Dates

Start date
Nov 30, 2002
Status verified
Apr 2008
Completion
May 31, 2005

Study Design

Enrollment
73 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A

Primary Outcome Measure

Overall response rate [ Time Frame: Week 6 ]

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