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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by:
Massachusetts General Hospital Identifier:
First received: November 9, 2004
Last updated: March 3, 2011
Last verified: March 2011

November 9, 2004
March 3, 2011
March 2003
March 2011   (final data collection date for primary outcome measure)
Response rate as assessed by RECIST criteria every 2 months [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00095836 on Archive Site
  • Toxicity as assessed by NCI CTC monthly [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
  • Progression-free survival as assessed by RECIST criteria every 2 months [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer

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.



  • 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.

Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
Drug: gefitinib
Taken orally once a day
Other Name: ZD1839
Not Provided
Pennell NA, Daniels GH, Haddad RI, Ross DS, Evans T, Wirth LJ, Fidias PH, Temel JS, Gurubhagavatula S, Heist RS, Clark JR, Lynch TJ. A phase II study of gefitinib in patients with advanced thyroid cancer. Thyroid. 2008 Mar;18(3):317-23.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
March 2011
March 2011   (final data collection date for primary outcome measure)


  • 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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
02-220, P30CA006516, ZENECA-IRUSIRES0165, CDR0000393510
Yariv Houvras, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • National Cancer Institute (NCI)
  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • AstraZeneca
Principal Investigator: John R Clark, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP