A Phase I/II Study of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), ZD 1839 (Iressa), [NSC #715055] With Radiation Therapy in Glioblastoma Multiforme

NCT00052208 Phase 1/Phase 2 COMPLETED

This phase I/II trial studies the side effects and best dose of gefitinib when given together with radiation therapy and to see how well it works in treating patients with glioblastoma multiforme. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving gefitinib together with radiation therapy may be an effective treatment for glioblastoma multiforme.

Details

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	158
Start date	2002-03

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma

Interventions

• gefitinib
• radiation therapy
• laboratory biomarker analysis

Primary outcomes

• Maximum tolerated dose of gefitinib defined as the dose at which no patients develop acute grade 5 toxicity and less than 30% of patients developed acute dose limiting toxicity graded by the National Cancer Institute Common Toxicity Criteria v2.0 — Within 90 days from the start of radiotherapy treatment
• Rate of late toxicities associated with gefitinib and standard cranial radiation, graded according to the NCI CTC v2.0 — Up to 10 years
• Overall survival, by EGFR status — Up to 10 years

Countries

United States