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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: | NCT00390325 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent medullary thyroid cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer Multiple Endocrine Neoplasia 1 and 2 (men1, men2) |
Drug: sorafenib tosylate Genetic: molecular genetic technique Genetic: mutation analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Sorafenib (BAY 43-9006) in Patients With Metastatic Medullary Thyroid Carcinoma |
Estimated Enrollment: | 50 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to clinical setting of disease (inherited tumor syndromes vs sporadic).
Patients receive oral sorafenib tosylate twice daily on days 1-56. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection and tumor biopsies for biomarker/laboratory studies (immunohistochemistry, pharmacogenomic studies, and genotyping) at baseline, every 8 weeks during treatment, and after completion of study treatment. Tumor markers may include carcinoembryonic antigen (CEA), calcitonin, and RET mutations.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 50 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 confirmed medullary thyroid carcinoma (MTC) meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent active anticoagulation with therapeutic intent
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Jeffrey F. Moley, MD 314-747-0064 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Manisha H. Shah, MD 614-293-8629 manisha.shah@osumc.edu |
Study Chair: | Manisha H. Shah, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Responsible Party: | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Miguel A. Villalona-Calero ) |
Study ID Numbers: | CDR0000507441, OSU-06054, NCI-7609 |
Study First Received: | October 18, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00390325 History of Changes |
Health Authority: | Unspecified |
thyroid gland medullary carcinoma recurrent thyroid cancer multiple endocrine neoplasia 1 and 2 (MEN1, MEN2) |
Carcinoma, Medullary Thyroid Neoplasms Thyroid Cancer, Medullary Endocrine System Diseases Protein Kinase Inhibitors Recurrence Carcinoma Neoplastic Syndromes, Hereditary |
Genetic Diseases, Inborn Head and Neck Neoplasms Multiple Endocrine Neoplasia Endocrinopathy Sorafenib Thyroid Diseases Endocrine Gland Neoplasms |
Molecular Mechanisms of Pharmacological Action Thyroid Neoplasms Antineoplastic Agents Neoplasms, Multiple Primary Endocrine System Diseases Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Therapeutic Uses Head and Neck Neoplasms Multiple Endocrine Neoplasia Sorafenib Thyroid Diseases Endocrine Gland Neoplasms |