A dose escalation study of biweekly oral vinorelbine and gemcitabine in patients with solid tumors

Oncology. 2006;71(5-6):347-53. doi: 10.1159/000107794. Epub 2007 Sep 3.


Purpose: To determine the maximum tolerated doses (MTDs) and the dose-limiting toxicities of a biweekly administration of oral vinorelbine and gemcitabine in patients with advanced solid tumors.

Patients and methods: Twenty-eight patients with advanced stage solid tumors were enrolled, and 12 (42.9%) of them were chemotherapy naive. Escalating doses of vinorelbine (50-70 mg/m2 per os) and gemcitabine (800-1,000 mg/m2 as a 30-min intravenous infusion) were administered on days 1 and 15 in 4-week cycles.

Results: MTDs were reached at 70 mg/m2 p.o. for vinorelbine and 900 mg/m2 for gemcitabine. Grade 4 neutropenia, febrile neutropenia, grade 4 nausea/vomiting and treatment delay due to grade 3 neutropenia were the dose-limiting events during the first cycle of chemotherapy. A total of 94 chemotherapy cycles were administered with only one episode of febrile neutropenia and no toxic deaths. Severe (grade 3-4) neutropenia occurred in 10% of cycles while non-hematological toxicity was mild with grade 2-3 asthenia occurring in 17 (18%) cycles. Objective responses were achieved in patients with prostate and non-small cell lung cancer.

Conclusions: The combination of biweekly oral vinorelbine (70 mg/m2) and gemcitabine (900 mg/m2) is a well-tolerated regimen with promising results in patients with advanced solid tumors.

Publication types

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

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Gemcitabine
  • Humans
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Nausea / chemically induced
  • Neoplasms / drug therapy*
  • Neutropenia / chemically induced
  • Treatment Outcome
  • Vinblastine / administration & dosage
  • Vinblastine / adverse effects
  • Vinblastine / analogs & derivatives*
  • Vinorelbine


  • Deoxycytidine
  • Vinblastine
  • Vinorelbine
  • Gemcitabine