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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00104871 |
Purpose
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic thyroid cancer that did not respond to radioactive iodine therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: bortezomib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Cancer |
| Estimated Enrollment: | 45 |
| Study Start Date: | December 2004 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 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 confirmed differentiated thyroid cancer
Papillary or follicular type, including, but not limited to, any of the following variants:
Measurable disease
Unresponsive to prior radioiodine therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
At least 6 months since prior external beam radiotherapy for locoregional disease in the thyroid bed or to the cervical or upper mediastinal lymph nodes
Surgery
Other
Contacts and Locations| United States, Colorado | |
| University of Colorado Cancer Center at UC Health Sciences Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Bryan R. Haugen, MD 303-315-8443 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| Canada, Ontario | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: J. D. Brierley, MD 416-946-2124 james.brierly@rmp.uhn.on.ca | |
| Study Chair: | Steven I. Sherman, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M. D. Anderson Cancer Center at University of Texas ( David James Stewart ) |
| Study ID Numbers: | CDR0000415376, MDA-2004-0059, NCI-6132 |
| Study First Received: | March 3, 2005 |
| Last Updated: | July 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00104871 History of Changes |
| Health Authority: | Unspecified |
|
stage II follicular thyroid cancer stage IV follicular thyroid cancer stage II papillary thyroid cancer |
stage IV papillary thyroid cancer insular thyroid cancer recurrent thyroid cancer |
|
Adenocarcinoma, Follicular Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Thyroid Neoplasms Antineoplastic Agents Bortezomib Endocrine System Diseases Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |
Carcinoma Neoplasms Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Adenocarcinoma Thyroid Diseases Endocrine Gland Neoplasms Neoplasms, Glandular and Epithelial |