Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
Condition: Head and Neck Cancer
MeSH terms: Thyroid Neoplasms
Intervention: Gefitinib
Intervention description: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent thyroid cancer; stage III follicular thyroid cancer; stage III papillary thyroid cancer; stage IV follicular thyroid cancer; stage IV papillary thyroid cancer; anaplastic thyroid cancer; thyroid gland medullary carcinoma

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed thyroid cancer, metastatic or locally
             advanced, not amenable or refractory to local therapy and/or radioactive iodine,
             depending on the cell type.

          2. Thyroid cancer that is unresponsive or refractory to radioactive iodine. All medullary
             and anaplastic thyroid carcinomas will be considered unresponsive on the basis of
             histopathologic diagnosis alone. Well-differentiated thyroid cancers (papillary and
             follicular) will be considered refractory if either there is no evidence of uptake on
             radioactive iodine scanning or tumor growth persists in spite of treatment with
             radioactive iodine.

          3. Measurable disease.

          4. Patient is at least 18 years of age.

          5. Eastern Cooperative Oncology Group performance status of 0-2.

          6. If female and of reproductive potential, a negative β-HCG (human chorionic
             gonadotropin) and use of effective birth control for the course of the study.

          7. Patient is capable of providing signed, informed consent.

        Exclusion Criteria:

          1. Concurrent chemotherapy, concurrent systemic anticancer treatment, or concurrent
             radiation therapy. Patients will not be excluded from the study on the basis of prior
             radiation therapy.

          2. Treatment with a non-approved or investigational drug within 30 days before Day 1 of
             trial treatment.

          3. Currently pregnant or nursing.

          4. Absolute neutrophil count <1.5 × 109/L, platelet count < 75 × 109/L, bilirubin > 1.5 ×
             normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 ×
             normal.

          5. Serum creatinine greater than Common Toxicity Criteria (CTC) grade 2.

          6. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, St John's Wort.

          7. Concomitant use of systemic retinoids, cyclosporine, verapamil, diltiazem,
             nicardipine, nifedipine, nitrendipine, erythromycin, theophylline, ketoconazole,
             itraconazole, and antihistamines such as terfenadine and astemizole.

          8. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
             therapy.

          9. Incomplete healing from previous oncologic or other major surgery.

         10. Known severe hypersensitivity to ZD1839 or any of the excipients of this product.

         11. As judged by the investigator, any evidence of severe or uncontrolled systemic disease

             (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).

         12. Evidence of any other significant clinical disorder or laboratory finding that makes
             it undesirable for the subject to participate in the trial.

         13. Any evidence of clinically active interstitial lung disease (patients with chronic
             stable radiographic changes who are asymptomatic need not be excluded)