Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
This trial has been completed.
|Condition||head and neck cancer|
|Sponsor||Massachusetts General Hospital|
|Collaborator||National Cancer Institute (NCI)|
|Start date||March 2003|
|End date||March 2011|
|Trial size||38 participants|
|Trial identifier||NCT00095836, 02-220, CDR0000393510, P30CA006516, ZENECA-IRUSIRES0165|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Gefitinib 250mg once daily for duration of benefit
Response rate as assessed by RECIST criteria every 2 months
time frame: Every 2 months
Toxicity as assessed by NCI CTC monthly
time frame: Every cycle
Progression-free survival as assessed by RECIST criteria every 2 months
time frame: Every 2 months
time frame: 5 years
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed thyroid cancer - Metastatic or locally advanced disease - Not amenable to OR unresponsive or refractory to local therapy and/or radioactive iodine, depending on cell type - Medullary and anaplastic thyroid carcinomas are considered unresponsive on the basis of histology alone - Well-differentiated papillary or follicular thyroid carcinomas are considered refractory if there is no evidence of uptake on radioactive iodine scanning OR the tumor progresses despite treatment with radioactive iodine - Measurable disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 75,000/mm^3 Hepatic - AST or ALT ≤ 3 times normal - Bilirubin ≤ 1.5 times normal - No unstable or uncompensated hepatic disease Renal - Creatinine ≤ Common Toxicity Criteria grade 2 - No unstable or uncompensated renal disease Cardiovascular - No unstable or uncompensated cardiac disease Pulmonary - No clinically active interstitial lung disease - Chronic, stable, asymptomatic radiographic changes allowed - No unstable or uncompensated respiratory disease Other - No known severe hypersensitivity to gefitinib or any of its excipients - No other severe or uncontrolled systemic disease - No other significant clinical disorder or laboratory finding that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No concurrent local-regional radiotherapy to a primary disease site - No concurrent radiotherapy to a bony or CNS metastasis Surgery - Completely healed after prior oncologic or other major surgery Other - Recovered from all prior anticancer therapy - More than 30 days since prior non-approved or investigational drugs - No concurrent use of any of the following agents: - Phenytoin - Carbamazepine - Barbiturates - Rifampin - Phenobarbital - Hypericum perforatum (St. John's wort) - Systemic retinoids - Cyclosporine - Verapamil - Diltiazem - Nicardipine - Nifedipine - Nitrendipine - Erythromycin - Theophylline - Ketoconazole - Itraconazole - Antihistamines (e.g., terfenadine or astemizole) - No concurrent grapefruit or grapefruit juice - No other concurrent systemic anticancer treatment
|Official title||A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer|
|Principal investigator||John R Clark, MD|
|Description||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.|
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