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Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
This study is ongoing, but not recruiting participants.
First Received: November 9, 2004   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095836
  Purpose

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 II

MedlinePlus related topics: Cancer Head and Neck Cancer Thyroid Cancer
Drug Information available for: ZD1839 Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as assessed by RECIST criteria every 2 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as assessed by NCI CTC monthly [ Designated as safety issue: Yes ]
  • Progression-free survival as assessed by RECIST criteria every 2 months [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Study Start Date: March 2003
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095836

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Robert I. Haddad, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000393510, DFCI-02220, ZENECA-IRUSIRES0165
Study First Received: November 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00095836     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Adenocarcinoma, Follicular
Carcinoma, Medullary
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Cancer, Medullary
Endocrine System Diseases
Protein Kinase Inhibitors
Recurrence
Carcinoma
Thyroid Cancer, Follicular
Head and Neck Neoplasms
Iodine
Thyroid Cancer, Anaplastic
Endocrinopathy
Gefitinib
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Thyroid Neoplasms
Antineoplastic Agents
Endocrine System Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Gefitinib
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009