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

Abstract

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.

• Authors: A Karampeazis, L Vamvakas, S Agelaki, N Kentepozidis, E Papadimitraki, I Gioulbasanis, N Vardakis, M Ignatiadis, D Mavroudis, V Georgoulias
• Journal: Oncology (Oncology) Vol. 71 Issue 5-6 Pg. 347-53 ( 2006) ISSN: 1423-0232 [Electronic] Switzerland
• PMID: 17785992 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2006 S. Karger AG, Basel.

Chemical References

• Deoxycytidine
• Vinblastine
• Vinorelbine
• Gemcitabine

Topics

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