Phase I and Pharmacokinetic Trial of Gemcitabine in Patients With Hepatic or Renal Dysfunction: Cancer and Leukemia Group B 9565

摘要: PURPOSE: To ascertain if hepatic or renal dysfunction leads to increased toxicity at a given dose of gemcitabine and characterize the pharmacokinetics its major metabolite in patients with such dysfunction. PATIENTS AND METHODS: Adults tumors appropriate for therapy who had abnormal liver function tests were eligible. Patients assigned one three treatment cohorts: I—AST level less than equal two times normal bilirubin 1.6 mg/dL; II—bilirubin 7.0 III—creatinine 5.0 mg/dL function. Doses explored least within each cohort. Gemcitabine be measured blood all patients. RESULTS: Forty assessable toxicity. Transient transaminase elevations observed many but not limiting. AST tolerated without toxicity, with...