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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
  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: Intervention Model: Single Group Assignment
Masking: None (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 John Ross Clark, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.


Enrollment: 27
Actual Study Start Date: March 2003
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib 250mg 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

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications:
Responsible Party: John Ross Clark, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00095836     History of Changes
Other Study ID Numbers: 02-220
P30CA006516 ( U.S. NIH Grant/Contract )
ZENECA-IRUSIRES0165 ( Other Identifier: AstraZeneca )
CDR0000393510 ( Registry Identifier: NCI PDQ )
Study First Received: November 9, 2004
Results First Received: March 1, 2017
Last Updated: May 2, 2017

Keywords provided by John Ross Clark, 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:
Head and Neck Neoplasms
Thyroid Diseases
Thyroid Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017