title: Toxicity of a 24-hour infusion of gemcitabine in biliary tract and pancreatic cancer: a pilot study.
abstract: The antitumor activity of gemcitabine is not dose-response related but schedule-dependent. Based on the results of a published phase I study in patients with nonsmall-cell lung cancer we started a pilot study of a 24-hr infusion of gemcitabine in patients with adenocarcinoma of the pancreas and biliary tract cancer. Twenty-five patients were enrolled and received a 24-hr infusion of gemcitabine once weekly on three consecutive out of 4 weeks. Dose levels of gemcitabine ranged from 100 to 150 mg/m2. One of 13 chemotherapy-naive patients had a partial response. Dose-limiting toxicity (DLT) was thrombocytopenia in pretreated patients and neutropenia in chemotherapy-naive patients. Other toxicities were oral mucositis, fever, flu-like symptoms, and asthenia. Maximum tolerated dose (MTD), especially in pretreated patients, was 100 mg/m2.
authors.affiliation: Department of Internal Medicine II, Technical University of Munich, Klinikum rechts der Isar, Ismaningerstr. 22, 81675 Munich, Germany. florian.eckel@lrz.tum.de
authors.forename: Florian
authors.initials: F
authors.lastname: Eckel
authors.forename: Christian
authors.initials: C
authors.lastname: Lersch
authors.forename: Gerald
authors.initials: G
authors.lastname: Assmann
authors.forename: Ewert
authors.initials: E
authors.lastname: Schulte-Frohlinde
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000633:toxicity*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000633:toxicity*; D005260:Female; D005706:Gallbladder Neoplasms / Q000188:drug therapy / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine