Journal of Neuro-Oncology

, Volume 78, Issue 3, pp 277–280 | Cite as

Vinorelbine combined with a protracted course of temozolomide for recurrent brain Metastases: a phase I trial

  • A.M. Omuro
  • J.J. Raizer
  • A. Demopoulos
  • M.G. Malkin
  • L.E. AbreyEmail author
Clinical–patient studies


Temozolomide (TMZ) has shown modest efficacy in the treatment of recurrent brain metastasis (BM). We designed a new regimen utilizing dose-intensified, protracted course of TMZ in combination with vinorelbine, a lipophilic large-spectrum agent, in an attempt to improve the efficacy of TMZ. This phase I study was conducted to establish the maximum tolerated dose (MTD) of vinorelbine for this combination. Patients with recurrent or progressive BM were eligible. Chemotherapy consisted of 28-day cycles with TMZ (150 mg/m2, days 1–7 and 15–21) and vinorelbine (days one and eight at escalating doses). The starting dose was 15 mg/m2, with increments of 5 mg/m2 for each cohort of 3–6 patients, until MTD was reached (30 mg/m2). A total of 21 patients were enrolled; the median age was 59 (41–77). The primary tumor was lung cancer in 13 patients (NSCLC in 10, SCLC in 3), breast in 6, renal in 1 and endometrial in 1. Vinorelbine dose was 15 mg/m2 in seven patients, 20 mg/m2 in five, 25 mg/m2 in four and 30 mg/m2 in six. Grades 3 and 4 neutropenia developed in six patients, lymphopenia in nine, and thrombocytopenia in six; other toxicities were rare. No dose-limiting toxicity was seen. Out of 18 evaluable patients 2 had a radiographic response (one partial and one minor). Disease was stable in 6 of 18 patients and the median survival was 27 weeks. This regimen was well tolerated and a phase II trial using a dose of 30 mg/m2 of vinorelbine is warranted.


Brain metastasis breast cancer chemotherapy clinical trial lung cancer temozolomide vinorelbine 


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Dr. Abrey has received honoraria and grant support from Schering Plough, Inc. This study was supported in part by an unrestricted educational grant from Schering Plough, Inc.


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Copyright information

© Springer Science+Business Media, Inc. 2006

Authors and Affiliations

  • A.M. Omuro
    • 1
  • J.J. Raizer
    • 1
  • A. Demopoulos
    • 1
  • M.G. Malkin
    • 1
  • L.E. Abrey
    • 1
    Email author
  1. 1.Department of NeurologyMemorial Sloan-Kettering Cancer CenterNew YorkUSA

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