A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas
- 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
Primary Purpose: Treatment
Michael Prados, MD
UCSF Medical Center at Parnassus
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|