Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
Recruitment status was Active, not recruiting
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic thyroid cancer that did not respond to iodine therapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer|
- Response rate as assessed by RECIST criteria every 2 months [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTC monthly [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
- Progression-free survival as assessed by RECIST criteria every 2 months [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||March 2011|
|Estimated Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
- Determine the all-measurable-disease response rate in patients with iodine-refractory locally advanced or metastatic thyroid cancer treated with gefitinib.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095836
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||John R Clark, MD||Massachusetts General Hospital|