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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Radiation Therapy Oncology Group
United States: Food and Drug Administration
|Radiation Therapy Oncology Group||Philadelphia, Pennsylvania 19107|