Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 1567
© 2004 American Society of Clinical Oncology

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Abstract

A phase I trial of temozolomide and vinorelbine in patients with recurrent brain metastases

Memorial Sloan-Kettering Cancer Center, New York, NY

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Background: The prognosis of recurrent brain metastasis (BM) is poor. We designed a Phase I trial combining temozolomide (TMZ), an agent with efficacy in BM, with vinorelbine, a lipophilic agent with activity against a variety of solid tumors, to establish the maximum tolerated dose (MTD) of vinorelbine for this combination. Methods: Patients with solid tumors and recurrent or progressive BM were eligible. Chemotherapy consisted of 28 day cycles with TMZ (150 mg/m² on days 1 to 7 and 15 to 21) and vinorelbine (days 1 and 8 at escalating doses). The starting dose was 15 mg/m², with increments of 5 mg/m² for each cohort of 3 patients, until MTD was reached. Results: 14 pts enrolled (5 men); median age was 59 (41–76) years; median KPS was 80 (70–100). Seven pts had non-small cell lung CA, 3 small-cell lung cancer, 3 breast and 1 renal cell. Vinorelbine dose/m² was 15mg in 7, 20mg in 4 and 25mg in 3. Six patients were taken off study for disease progression, 3 for toxicity, 3 for withdrawal of consent, 1 for clinical deterioration and 1 for non-compliance. The median time to progression was 3 (1–7) months. Of the 10 that completed at least one cycle, 1 achieved a minor response, 3 stable disease and 6 progressed (5 in the brain, 1 systemically). Median overall survival was 7.5 (2–13) months. Grades 3/ 4 neutropenia in 4 patients and thrombocytopenia in 5 were the only serious adverse events. Conclusions: To date this regimen has been well tolerated and a phase II study is warranted to define efficacy.

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Schering-Plough Integrated Therapeutics (Schering-Plough)

Abstract presentation from the 2004 ASCO Annual Meeting