title: Weekly carboplatin and docetaxel for locally advanced primary and recurrent cervical cancer: a phase I study.
abstract: OBJECTIVE
  The aim of this study was to determine the dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) of a docetaxel-carboplatin regimen in patients with locally advanced cervical cancer (LACC) or recurrent cervical cancer. The regimen was administered weekly, with a maximum of 12 courses.
  
  
  METHODS
  Twenty patients were treated with with a total of 145 cycles of weekly carboplatin and docetaxel. The starting dose of docetaxel was 25 mg/m(2) with increments of 5 mg/m(2) until a final dose of 35 mg/m(2) was reached. Dose-escalation of docetaxel was followed by carboplatin at AUC 2, AUC 2.5, and AUC 3, respectively. Defined dose-limiting toxicities were WHO grade (G) 3 hematotoxicity, G4 mucositis, and G2 neurotoxicity. The response status of the patients was assessed using the common ECOG response criteria.
  
  
  RESULTS
  Two of four patients developed a DLT at dose level 4. Nonhematological toxicity was generally mild, except for ubiquitous complete alopecia. The MTD was reached at docetaxel 35 mg/m(2) and carboplatin AUC 2 mg/mL.min. The overall response rate was 65% in the entire group of evaluable patients and 77% in patients with primary LACC, with two cases of pathological complete response.
  
  
  CONCLUSIONS
  This dose-dense regimen was well-tolerated and could be administered on an outpatient basis.
authors.affiliation: Department of Gynecology and Obstetrics, University of Düsseldorf, Postfach 10 10 07, 40001 Düsseldorf, Germany. rein@med.uni-duesseldorf.de
authors.forename: D T
authors.initials: DT
authors.lastname: Rein
authors.forename: C M
authors.initials: CM
authors.lastname: Kurbacher
authors.forename: M
authors.initials: M
authors.lastname: Breidenbach
authors.forename: T
authors.initials: T
authors.lastname: Schöndorf
authors.forename: T
authors.initials: T
authors.lastname: Schmidt
authors.forename: E
authors.initials: E
authors.lastname: König
authors.forename: U-J
authors.initials: UJ
authors.lastname: Göhring
authors.forename: J-U
authors.initials: JU
authors.lastname: Blohmer
authors.forename: P
authors.initials: P
authors.lastname: Mallmann
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D043823:Taxoids; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin; D017239:Paclitaxel