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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Objective Tumor Response Rate at 3, 6, and 12 Months
Response rate as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Tumor assessment is performed within 4 weeks of initiation of treatment and then every 8 weeks. If a patient has stable disease for four tumor assessments (6 months), then tumor assessment may occur every 4 months. If the patient continues to experience stable disease after 2 years, tumor assessments may occur every 6 months. If the patient continues to experience stable disease after 5 years, tumor assessments may occur once a year. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Time frame: 3 Months, 6 Months, 1 Year
Toxicity
Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients
Time frame: Through study completion, on average 12 months
Median Progression-free Survival
The median progression-free survival as assessed by RECIST criteria (Response Evaluation Criteria In Solid Tumors) measured from the time of enrollment until disease progression or death. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of new lesions.
Time frame: From the time of enrollment until disease progression or death, whichever came first
Overall Survival
The median overall survival time, measured from the time of enrollment until death.
Time frame: 5 years
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