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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.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Brigham and Women's Hospital
AstraZeneca
Information provided by (Responsible Party):
John Ross Clark, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00095836
First received: November 9, 2004
Last updated: May 2, 2017
Last verified: May 2017
November 9, 2004
May 2, 2017
March 2003
March 2011   (Final data collection date for primary outcome measure)
Objective Tumor Response Rate at 3, 6, and 12 Months [ Time Frame: 3 Months, 6 Months, 1 Year ]

Response rate as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Tumor assessment is performed within 4 weeks of initiation of treatment and then every 8 weeks. If a patient has stable disease for four tumor assessments (6 months), then tumor assessment may occur every 4 months. If the patient continues to experience stable disease after 2 years, tumor assessments may occur every 6 months. If the patient continues to experience stable disease after 5 years, tumor assessments may occur once a year.

Complete Response (CR): Disappearance of all target lesions

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Not Provided
Complete list of historical versions of study NCT00095836 on ClinicalTrials.gov Archive Site
  • Toxicity [ Time Frame: Through study completion, on average 12 months ]
    Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients
  • Median Progression-free Survival [ Time Frame: From the time of enrollment until disease progression or death, whichever came first ]

    The median progression-free survival as assessed by RECIST criteria (Response Evaluation Criteria In Solid Tumors) measured from the time of enrollment until disease progression or death.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of new lesions.

  • Overall Survival [ Time Frame: 5 years ]
    The median overall survival time, measured from the time of enrollment until death.
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
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Head and Neck Cancer
Drug: Gefitinib
Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Other Names:
  • ZD1839
  • IRESSA
Experimental: Gefitinib 250mg
Intervention: Drug: Gefitinib
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.
 
Completed
27
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histologically or cytologically confirmed thyroid cancer, metastatic or locally advanced, not amenable or refractory to local therapy and/or radioactive iodine, depending on the cell type.
  2. Thyroid cancer that is unresponsive or refractory to radioactive iodine. All medullary and anaplastic thyroid carcinomas will be considered unresponsive on the basis of histopathologic diagnosis alone. Well-differentiated thyroid cancers (papillary and follicular) will be considered refractory if either there is no evidence of uptake on radioactive iodine scanning or tumor growth persists in spite of treatment with radioactive iodine.
  3. Measurable disease.
  4. Patient is at least 18 years of age.
  5. Eastern Cooperative Oncology Group performance status of 0-2.
  6. If female and of reproductive potential, a negative β-HCG (human chorionic gonadotropin) and use of effective birth control for the course of the study.
  7. Patient is capable of providing signed, informed consent.

Exclusion Criteria:

  1. Concurrent chemotherapy, concurrent systemic anticancer treatment, or concurrent radiation therapy. Patients will not be excluded from the study on the basis of prior radiation therapy.
  2. Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
  3. Currently pregnant or nursing.
  4. Absolute neutrophil count <1.5 × 109/L, platelet count < 75 × 109/L, bilirubin > 1.5 × normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × normal.
  5. Serum creatinine greater than Common Toxicity Criteria (CTC) grade 2.
  6. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, St John's Wort.
  7. Concomitant use of systemic retinoids, cyclosporine, verapamil, diltiazem, nicardipine, nifedipine, nitrendipine, erythromycin, theophylline, ketoconazole, itraconazole, and antihistamines such as terfenadine and astemizole.
  8. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
  9. Incomplete healing from previous oncologic or other major surgery.
  10. Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
  11. As judged by the investigator, any evidence of severe or uncontrolled systemic disease

    (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).

  12. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
  13. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00095836
02-220
P30CA006516 ( U.S. NIH Grant/Contract )
ZENECA-IRUSIRES0165 ( Other Identifier: AstraZeneca )
CDR0000393510 ( Registry Identifier: NCI PDQ )
Yes
Not Provided
Not Provided
John Ross Clark, 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
May 2017

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