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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00095693 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of sorafenib in treating patients who have locally advanced, metastatic, or locally recurrent thyroid cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma |
Study Start Date: | November 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (papillary thyroid cancer that is chemonaïve vs all others).
Patients receive oral sorafenib (BAY 43-9006) twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission (CR) receive 8 additional weeks of therapy beyond CR.
Patients are followed within 2-4 weeks after completion of study treatment.
PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 7 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Papillary, follicular, Hurthle cell, insular, or anaplastic thyroid cancer (stratum II)
At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
The following are considered non-measurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior systemic chemotherapy for thyroid cancer (stratum I)
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 |
Study Chair: | Manisha H. Shah, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000393968, OSU-0441, OSU-2004C0068, NCI-6608 |
Study First Received: | November 5, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00095693 |
Health Authority: | United States: Federal Government |
anaplastic thyroid cancer insular thyroid cancer recurrent thyroid cancer stage III follicular thyroid cancer |
stage III papillary thyroid cancer stage IV follicular thyroid cancer stage IV papillary thyroid cancer |
Adenocarcinoma, Follicular Thyroid Neoplasms Endocrine System Diseases Recurrence Carcinoma Thyroid cancer, papillary Head and Neck Neoplasms |
Endocrinopathy Sorafenib Thyroid Diseases Thyroid cancer, anaplastic Thyroid cancer, follicular Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |