Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma
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
2 other identifiers
interventional
73
4 countries
9
Brief Summary
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2002
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedApril 7, 2008
April 1, 2008
March 5, 2008
April 2, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate
Week 6
Secondary Outcomes (7)
Time to progression
Weeks 6, 12, 18, 24, 36, and 1 year
Duration of overall response
Weeks 6, 12, 18, 24, 36, and 1 year
Overall tumour growth control rate
Weeks 6, 12, 18, 24, 36, and 1 year
Overall survival
Weeks 6, 12, 18, 24, 36, and 1 year
Adverse events
Weeks 6, 12, 18, 24, 36, and 1 year
- +2 more secondary outcomes
Study Arms (1)
A
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (9)
Pfizer Investigational Site
Shanghai, 200433, China
Pfizer Investigational Site
Hong Kong SAR, Hong Kong
Pfizer Investigational Site
Seoul, 135-710, South Korea
Pfizer Investigational Site
Seoul, 136-705, South Korea
Pfizer Investigational Site
Seoul, 138-736, South Korea
Pfizer Investigational Site
Seoul, 152-703, South Korea
Pfizer Investigational Site
Keelung, 204, Taiwan
Pfizer Investigational Site
Taipei, 112, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 13, 2008
Study Start
November 1, 2002
Study Completion
May 1, 2005
Last Updated
April 7, 2008
Record last verified: 2008-04