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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00126568 |
Purpose
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 advanced anaplastic thyroid cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: sorafenib tosylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid |
| Enrollment: | 20 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed anaplastic* thyroid cancer
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 2 prior systemic cytotoxic chemotherapy regimens
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
Contacts and Locations| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Michigan | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| UH-Chagrin Highlands | |
| Orange Village, Ohio, United States, 44122 | |
| UH-Westlake | |
| Westlake, Ohio, United States, 44145 | |
| United States, West Virginia | |
| West Virginia University | |
| Morgantown, West Virginia, United States, 26506 | |
| Principal Investigator: | Panayiotis Savvides, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00126568 History of Changes |
| Other Study ID Numbers: | CASE5304, U01CA062502, P30CA043703, CASE-5304, NCI-7037 |
| Study First Received: | August 2, 2005 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
anaplastic thyroid cancer recurrent thyroid cancer |
|
Thyroid Neoplasms Head and Neck Neoplasms Carcinoma Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases Thyroid Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |