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

This study has been completed.
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
John Ross Clark, Massachusetts General Hospital Identifier:
First received: November 9, 2004
Last updated: November 3, 2016
Last verified: November 2016

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 Intervention Phase
Head and Neck Cancer
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Response rate as assessed by RECIST criteria every 2 months [ Time Frame: Every 2 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 38
Study Start Date: March 2003
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib
Gefitinib 250mg once daily for duration of benefit
Drug: gefitinib
Taken orally once a day
Other Name: ZD1839

Detailed Description:



  • Determine the all-measurable-disease response rate in patients with iodine-refractory locally advanced or metastatic thyroid cancer treated with gefitinib.


  • 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 older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3


  • AST or ALT ≤ 3 times normal
  • Bilirubin ≤ 1.5 times normal
  • No unstable or uncompensated hepatic disease


  • Creatinine ≤ Common Toxicity Criteria grade 2
  • No unstable or uncompensated renal disease


  • No unstable or uncompensated cardiac disease


  • No clinically active interstitial lung disease

    • Chronic, stable, asymptomatic radiographic changes allowed
  • No unstable or uncompensated respiratory disease


  • 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


Biologic therapy

  • Not specified


  • No concurrent chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No concurrent local-regional radiotherapy to a primary disease site
  • No concurrent radiotherapy to a bony or CNS metastasis


  • Completely healed after prior oncologic or other major surgery


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00095836

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: John R Clark, MD Massachusetts General Hospital
  More Information

Responsible Party: John Ross Clark, Physician, Massachusetts General Hospital Identifier: NCT00095836     History of Changes
Other Study ID Numbers: 02-220
P30CA006516 ( US NIH Grant/Contract Award Number )
CDR0000393510 ( Registry Identifier: NCI PDQ )
Study First Received: November 9, 2004
Last Updated: November 3, 2016

Keywords provided by Massachusetts General Hospital:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Thyroid Diseases
Thyroid Neoplasms
Neoplasms by Site
Endocrine System Diseases
Endocrine Gland Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017