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
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
AstraZeneca
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00095836
First received: November 9, 2004
Last updated: March 3, 2011
Last verified: March 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 38
Study Start Date: March 2003
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: gefitinib
    Taken orally once a day
    Other Name: ZD1839
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095836

Locations
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
Dana-Farber Cancer Institute
Brigham and Women's Hospital
AstraZeneca
Investigators
Principal Investigator: John R Clark, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Yariv Houvras, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00095836     History of Changes
Other Study ID Numbers: 02-220, P30CA006516, ZENECA-IRUSIRES0165, CDR0000393510
Study First Received: November 9, 2004
Last Updated: March 3, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014