Pharmacokinetic Study of Adjuvant Gemcitabine Therapy for Biliary Tract Cancer after Hepatectomy (KHBO1101)
Phase 1
- Conditions
- Biliary Tract Cancer
- Registration Number
- JPRN-UMIN000005109
- Lead Sponsor
- Kansai Hepatobiliary Oncology Group
- Brief Summary
We observed the following toxicities: neutropenia (n = 11, 91.7%), leukopenia (n = 10, 83.3%), thrombocytopenia (n = 6, 50.0%), and infection (n = 5, 41.7%). Grade 3 or 4 neutropenia was observed in 25% (n = 3) of patients. There were differences in clearance of gemcitabine and dFdU between our subjects and the subjects who had not undergone hepatectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
Not provided
Exclusion Criteria
1)History of severe drug allergy 2)Severe comorbid disease(pulmonary fibrosis or interstitial pneumonia, etc.) 3)Active infection 4)Known to be positive for hepatitis B and C virus 5)Pregnant of breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of gemcitabine and gemcitabine metabolites
- Secondary Outcome Measures
Name Time Method Relationship between the pharmacokinetics of gemcitabine and gemcitabine metabolites and adverse events