Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy

Summary: 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.

Detailed 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.

Eligibility: 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

Relevance to patient case: not relevant