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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00095836 |
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 |
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Head and Neck Cancer |
Drug: gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer |
Study Start Date: | March 2003 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed thyroid cancer
Not amenable to OR unresponsive or refractory to local therapy and/or radioactive iodine, depending on cell type
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No clinically active interstitial lung disease
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent use of any of the following agents:
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 |
Study Chair: | Robert I. Haddad, MD | Dana-Farber Cancer Institute |
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 |
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 |
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 |
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 |