NCT00027625

Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma

A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	gefitinib
DRUG	temozolomide

Timeline

• Start date: 2002-01-28
• Primary completion: 2005-03-17
• Completion: 2005-11-01
• First posted: 2003-01-27
• Last updated: 2018-06-27

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study