This trial is active, not recruiting.

Condition head and neck cancer
Treatment gefitinib
Phase phase 2
Target EGFR
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Response rate as assessed by RECIST criteria every 2 months
time frame: Every 2 months

Secondary Outcomes

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
Overall survival
time frame: 5 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.