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.

Condition	Treatment or Intervention	Phase
anaplastic thyroid cancer follicular thyroid cancer medullary thyroid cancer papillary thyroid cancer Thyroid Cancer	Drug: gefitinib  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States; Recruiting

Study chairs or principal investigators

Robert I. Haddad, MD,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000393510; DFCI-02220; ZENECA-IRUSIRES0165; NCT00095836
Record last reviewed:  October 2004
Last Updated:  February 4, 2005
Record first received:  November 9, 2004
ClinicalTrials.gov Identifier:  NCT00095836
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08