Phase II Study Of ZD1839 (NSC 715055) In Newly Diagnosed Patients With Glioblastoma (Grade 4 Astrocytoma)
I. Determine treatment effectiveness of gefitinib, in terms of response rate, time to
progression, survival at 52 weeks, progression-free survival at 6 months, and overall
survival, in patients with newly diagnosed glioblastoma multiforme.
II. Determine the toxic effects of this drug in these patients. III. Assess fatigue,
depression, excessive daytime somnolence, and quality of life in patients treated with this
IV. Assess individual variation in responses, pharmacokinetic parameters, and/or biological
correlates due to genetic differences in enzymes involved in transport, metabolism, and/or
mechanism of action of this drug in these patients.
V. Determine if the type of epidermal growth factor receptor affects tumor response and
outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each treatment course, every 4 months for 1
year, every 6 months for 4 years, and then annually for 5 years.
Patients are followed every 8 weeks until tumor progression and then every 3 months for 5
years and annually for up to 10 years. Patients removed from study treatment for reasons
other than disease progression are followed every 4 months for 1 year, every 6 months for 4
years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study within 14 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of 'successes' will be estimated using the binomial point estimator (number of 'successes' divided by the total number of evaluable patients) and standard binomial 90% confidence interval estimates. In the unlikely event that accrual has not been completed before the interim analyses are performed, the Duffy-Santner lgorithm will be used to calculate 90% confidence intervals.
North Central Cancer Treatment Group
United States: Food and Drug Administration
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