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

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 ClinicalTrials.gov 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.

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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
38
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00095836
02-220, P30CA006516, ZENECA-IRUSIRES0165, CDR0000393510
Yes
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