A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer
OBJECTIVES:
Primary
- Determine the all-measurable-disease response rate in patients with iodine-refractory
locally advanced or metastatic thyroid cancer treated with gefitinib.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine progression-free and overall survival of patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate as assessed by RECIST criteria every 2 months
Every 2 months
No
John R Clark, MD
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
02-220
NCT00095836
March 2003
March 2011
Name | Location |
---|---|
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |