ZD1839 FOR Treatment Of Recurrent Or Progressive Malignant Astrocytoma Or Glioblastoma And Recurrent Or Progressive Meningioma: A Phase II Study With A Phase I Component For Patients Receiving EIAEDs
- Determine the maximum tolerated dose of gefitinib in patients with recurrent or
progressive supratentorial malignant gliomas or brain or spinal meningiomas receiving
enzyme-inducing antiepileptic drugs (EIAEDs). (Phase I of the study closed to accrual
as of 09/19/2003).
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in patients receiving EIAEDs.
- Determine the efficacy of this drug in terms of 6-month progression-free survival of
- Determine the safety profile of the phase II dose of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to
concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no) and disease type (for
phase II only) (benign meningioma vs malignant meningioma vs hemangiopericytoma vs
glioblastoma vs other anaplastic glioma). (Phase I closed to accrual as of 09/19/2003).
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients (who are receiving EIAEDs) receive escalating doses of gefitinib
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A minimum of 30 patients will be accrued for the phase I portion of this
study within 10 months . (Phase I closed to accrual as of 09/19/2003). A total of 48
patients will be accrued for the phase II portion of this study within 6-8 months.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6 months
Frank S. Lieberman, MD
University of Pittsburgh
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|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|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15236|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390-9063|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Neuro-Oncology Branch||Bethesda, Maryland 20892-8200|