Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer
cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop
tumor cells from dividing so they stop growing or die. Combining gefitinib with chemotherapy
may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining gefitinib with temozolomide in
treating patients who have malignant primary glioma.
OBJECTIVES:
- Determine the maximum tolerated dose of gefitinib when given in combination with
temozolomide in patients with malignant primary glioma.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of gefitinib. Patients are stratified
according to use of concurrent enzyme-inducing anti-epileptic drugs (yes vs no).
Patients receive oral gefitinib once daily on days 1-35 and oral temozolomide once daily on
days 8-12 for the first course only. For the second and subsequent courses, patients receive
oral gefitinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed every 2 months for 1 year and then every 3-6 months thereafter.
PROJECTED ACCRUAL: Approximately 3-42 patients will be accrued for this study within 1-14
months.
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