A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases
- Determine the maximum tolerated dose of vinorelbine when administered in combination
with temozolomide in patients with recurrent brain metastases (phase I accrual
- Determine the safety and feasibility of this treatment regimen in these patients.
- Determine the efficacy of this treatment regimen, in terms of objective radiographic
response and overall and progression-free survival, in these patients.
OUTLINE: This is a dose-escalation study of vinorelbine.
Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and oral temozolomide once
daily on days 1-7 and 15-21. Courses repeat every 28 days for up to 1 year in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6
patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-35
patients will be treated at that dose level.
Patients are followed every 3-4 months.
PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for the phase I portion of this
study and 20-35 patients will be accrued for the phase II portion of this study within 2
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (phase I) assessed by NCI CTC at 2 months
Lauren E. Abrey, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|