A phase I trial of docetaxel and vinorelbine in patients with advanced non-small cell lung cancer

Oncol Rep. 2006 Jan;15(1):123-7.

Abstract

Advanced non-small cell lung cancer (NSCLC) remains a difficult cancer to treat, and evolution of platinum-free regimens in a first-line setting is ongoing. This was a dose-finding study on the docetaxel and vinorelbine combination. Docetaxel was given at 60 mg/m(2) on day 1 only, and vinorelbine was given on days 1 and 15 starting at 20 mg/m(2), then escalated to 30 and 40 mg/m(2) in two dose cohorts. Each cycle lasted 28 days. The maximum tolerated dose was 60 mg/m(2) docetaxel and 30 mg/m(2) vinorelbine. Twenty-one patients were enrolled and showed an overall response rate of 9.5%, with stable disease documented in 33% of patients. The dosage schedule of this combination resulted in acceptable toxicities. The median time to progression was 5.86 months (95% CI 2.50-9.22), and median survival was 10.96 months (95% CI 1.42-20.51) with a 1-year survival rate of 50%. This combination may be important for patients with NSCLC.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / mortality
  • Docetaxel
  • Female
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / mortality
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Taxoids / adverse effects
  • Taxoids / therapeutic use*
  • Treatment Outcome
  • Vinblastine / adverse effects
  • Vinblastine / analogs & derivatives*
  • Vinblastine / therapeutic use
  • Vinorelbine

Substances

  • Taxoids
  • Docetaxel
  • Vinblastine
  • Vinorelbine