title: A phase I trial of gemcitabine, docetaxel and carboplatin administered every 2 weeks as first line treatment in patients with advanced breast cancer.
abstract: OBJECTIVE
  To determine the maximum tolerated doses (MTDs) and dose limiting toxicities (DLTs) of gemcitabine (GEM), docetaxel (DOC) and carboplatin (CARBO) combination.
  
  
  METHODS
  A total of 33 previously untreated HER-2 negative patients with stage IIIB-IV breast cancer received escalated doses of GEM, DOC and CARBO all given sequentially on day 1 every 2 weeks. Twenty-three patients (70%) had previously received adjuvant or neoadjuvant chemotherapy.
  
  
  RESULTS
  The recommended MTDs are GEM 1,500 mg/m(2), DOC 50 mg/m(2) and CARBO 3AUC. Seven dose levels were evaluated and neutropenia was the primary dose-limiting event. Of 319 chemotherapy cycles delivered, grade 3-4 neutropenia occurred in 13.5% of them with two cases of febrile neutropenia. Diarrhea and asthenia were the most common non-hematological toxicities. Three (16%) complete and 6 (32%) partial responses were observed among 19 patients with measurable disease.
  
  
  CONCLUSIONS
  The biweekly administration of GEM, DOC and CARBO is a well-tolerated regimen which merits further evaluation.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece.
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Bozionelou
authors.forename: Kostas
authors.initials: K
authors.lastname: Kalbakis
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Sofia
authors.initials: S
authors.lastname: Agelaki
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Androulakis
authors.forename: Antonia
authors.initials: A
authors.lastname: Kalykaki
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
authors.forename: Dimitris
authors.initials: D
authors.lastname: Mavroudis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D016190:Carboplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D016190:Carboplatin; D000093542:Gemcitabine