Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT00052208|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma||Drug: gefitinib Radiation: radiation therapy Other: laboratory biomarker analysis||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||June 2005|
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.
Radiation: radiation therapy
Undergo radiation therapy
Other: laboratory biomarker analysis
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052208
|United States, Pennsylvania|
|Radiation Therapy Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Arnab Chakravarti||Radiation Therapy Oncology Group|