NCT00014170

Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Phase II Study Of ZD1839 (NSC 715055) In Newly Diagnosed Patients With Glioblastoma (Grade 4 Astrocytoma)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed description

OBJECTIVES: 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 drug. 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.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma

Interventions

Type	Name	Description
DRUG	gefitinib	Given orally
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2001-03-01
• Primary completion: 2003-07-01
• First posted: 2003-06-10
• Last updated: 2013-07-16

Locations

1 site across 1 country: United States