Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma||Drug: gefitinib Radiation: radiation therapy Other: laboratory biomarker analysis||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- 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 [ Time Frame: 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 [ Time Frame: Up to 10 years ]
- Overall survival, by EGFR status [ Time Frame: Up to 10 years ]
- Progression-free survival [ Time Frame: Up to 10 years ]
|Study Start Date:||March 2002|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Experimental: Treatment (gefitinib, radiation therapy)
Patients receive gefitinib PO QD for 7 weeks. Beginning 1 week after initiation of gefitinib, patients undergo radiation therapy QD 5 days a week for 6 weeks. Treatment with gefitinib continues for up to 18 months in the absence of disease progression or unacceptable toxicity.
Other Names:Radiation: radiation therapy
Undergo radiation therapy
Other Names:Other: laboratory biomarker analysis
I. To identify the maximum tolerated dose of ZD 1839 (gefitinib) when given concurrently with cranial radiotherapy.
II. To determine if ZD 1839, given orally on a daily basis starting at the time of conventional radiation therapy (RT), may improve the overall survival of adults with newly-diagnosed supratentorial glioblastoma multiforme, compared with historical controls, stratifying by epidermal growth factor receptor (EGFR) status.
III. To determine, in a multi-institutional setting, the feasibility and toxicity of prescribing ZD 1839.
I. Whether ZD 1839 also improves progression-free survival in these patients.
OUTLINE: This is a phase I, dose-escalation study of gefitinib followed by a phase II study.
Patients receive gefitinib orally (PO) once daily (QD) for 7 weeks. Beginning 1 week after initiation of gefitinib, patients undergo radiation therapy QD 5 days a week for 6 weeks. Treatment with gefitinib continues for up to 18 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 2 years, and annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052208
|United States, Pennsylvania|
|Radiation Therapy Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Arnab Chakravarti||Radiation Therapy Oncology Group|