title: A phase I study of gemcitabine and docetaxel for advanced stage solid tumors.
abstract: BACKGROUND
  We conducted a phase I study to determine the maximum tolerated dose of docetaxel in combination with gemcitabine for patients with refractory solid tumors.
  
  
  METHODS
  From January 1998 to November 1999, we treated 28 patients on a phase I protocol with gemcitabine given at a constant dose of 800 mg/m2 i.v. over 30 minutes on days 1, 8, and 15. Docetaxel was administered by a phase I schedule over 1 hour on day 1 of a 28-day cycle with a starting dose of 50 mg/m2 and increased by increments of 10 mg/m2 based on dose-limiting toxicity (DLT) that occurred in the first cycle.
  
  
  RESULTS
  Neutropenia and thrombocytopenia were the dose-limiting toxicities. The maximum tolerated dose was 60 mg/m2. The most significant nonhematologic toxicities included fatigue, nausea, vomiting, mucositis, and hypersensitivity reactions. There was one partial response at 15 months in a patient with gastric cancer and six patients with stable disease for 4.0 to 15.0 months.
  
  
  CONCLUSIONS
  The maximum tolerated dose of docetaxel with gemcitabine is 60 mg/m2. A Phase II study in selected primary sites is planned.
authors.affiliation: Division of Hematology/Oncology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. poolem@med.unc.edu
authors.forename: Michael E
authors.initials: ME
authors.lastname: Poole
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Bernard
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Churchel
authors.forename: Mark C
authors.initials: MC
authors.lastname: Weissler
authors.forename: Benjamin
authors.initials: B
authors.lastname: Calvo
authors.forename: William
authors.initials: W
authors.lastname: Cance
authors.forename: David
authors.initials: D
authors.lastname: Ollila
authors.forename: Mark
authors.initials: M
authors.lastname: Koruda
authors.forename: Kevin
authors.initials: K
authors.lastname: Behrns
authors.forename: Frank C
authors.initials: FC
authors.lastname: Detterbeck
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D003841:Deoxycytidine / Q000009:adverse effects* / Q000031:analogs & derivatives*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000145:classification / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000009:adverse effects* / Q000031:analogs & derivatives*; D018579:Patient Selection; D043823:Taxoids; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D017239:Paclitaxel; D000093542:Gemcitabine