Metastatic Cancer Clinical Trial
Official title:
A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in
treating patients who have recurrent brain metastases.
OBJECTIVES:
- Determine the maximum tolerated dose of vinorelbine when administered in combination
with temozolomide in patients with recurrent brain metastases (phase I accrual
completed).
- 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
years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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