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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00381641 |
Purpose
RATIONALE: Sunitinib 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 the side effects and how well sunitinib works in treating patients with thyroid cancer that did not respond to iodine I 131 (radioactive iodine) and cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: sunitinib malate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Sunitinib (SU11248) in Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers and Medullary Thyroid Cancers |
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2006 |
| Estimated Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label, parallel-group, cohort, multicenter study. Patients are assigned to 1 of 2 cohorts according to type of thyroid cancer (medullary vs well-differentiated).
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Well-differentiated thyroid carcinoma (WDTC), including any of the following subtypes:
Measurable disease meeting 1 of the following criteria:
No known brain metastases
PATIENT CHARACTERISTICS:
No condition that would impair ability to swallow and retain sunitinib malate tablets, including any of the following:
Patients with any of the following conditions must have NYHA class II cardiac function confirmed on baseline ECHO/MUGA scan
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic doses of coumarin-derivative anticoagulants, such as warfarin
No concurrent agents with proarrhythmic potential, including any of the following:
At least 7 days since prior and no concurrent inhibitors of CYP3A4, including any of the following:
At least 12 days since prior and no concurrent inducers of CYP3A4, including any of the following:
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Oncology Care Associates, PLLC | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Missouri | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Chair: | Ezra Cohen, MD | University of Chicago |
More Information
| Responsible Party: | Everett E. Vokes, University of Chicago Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00381641 History of Changes |
| Other Study ID Numbers: | CDR0000502260, UCCRC-14696A, NCI-7735 |
| Study First Received: | September 26, 2006 |
| Last Updated: | October 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
thyroid gland medullary carcinoma stage IV follicular thyroid cancer stage IV papillary thyroid cancer |
recurrent thyroid cancer stage II follicular thyroid cancer stage II papillary thyroid cancer |
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Thyroid Neoplasms Head and Neck Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases Sunitinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |