Clinical dose-finding and pharmacokinetic study of gemcitabine in patients with biliary tract or pancreatic cancer with liver dysfunctio
Phase 1
Recruiting
- Conditions
- biliary tract cancer or pancreatic cancer with liver dysfunction
- Registration Number
- JPRN-UMIN000005363
- Lead Sponsor
- agoya university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients have received in the past gemcitabine hydrochloride monotherapy 2) Total bilirubin >10x ULN 3) Serum creatinin >1.5x ULN 4) Performance status 2 in classification of severe liver dysfunction 5) patients with interstitial pneumonia or pulmonary fibrosis on chest X-ray and having clinical symptoms 6) Patients with infections requiring treatment 7) Patients with uncontrolled diabetes despite the enforcement of appropriate drug therapy (including insulin) 8) it is clear that patients with constitutional jaundice 9) HBc antibody, HCV antibody, HIV antibody or syphilis positive 10) In addition, patients were judged inappropriate to participate in the clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance status, hematologic toxicity, and non-hematological toxicity during the first course of gemcitabine
- Secondary Outcome Measures
Name Time Method Pharmacokinetics