A phase I trial of gemcitabine, docetaxel and carboplatin administered every 2 weeks as first line treatment in patients with advanced breast cancer

Cancer Chemother Pharmacol. 2009 Sep;64(4):785-91. doi: 10.1007/s00280-009-0928-6. Epub 2009 Jan 22.


Objective: To determine the maximum tolerated doses (MTDs) and dose limiting toxicities (DLTs) of gemcitabine (GEM), docetaxel (DOC) and carboplatin (CARBO) combination.

Patients and 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.

Conclusion: The biweekly administration of GEM, DOC and CARBO is a well-tolerated regimen which merits further evaluation.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Carboplatin / administration & dosage
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Docetaxel
  • Female
  • Gemcitabine
  • Humans
  • Maximum Tolerated Dose
  • Middle Aged
  • Taxoids / administration & dosage


  • Taxoids
  • Deoxycytidine
  • Docetaxel
  • Carboplatin
  • Gemcitabine