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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: | Masking: Open Label Primary Purpose: Treatment |
| 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, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Jacqueline Jonklaas, MD 202-687-7319 jj@bc.georgetown.edu | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Fadlo R. Khuri, MD 404-778-4250 | |
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Marshall R. Posner, MD 617-632-3090 marshall_posner@dfci.harvard.edu | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| 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 | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Manisha H. Shah, MD 303-315-8443 manisha.shah@osumc.edu | |
| 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 | |
| London Regional Cancer Program at London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Contact: Eric Winquist, MD 519-685-8600 | |
| 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: | David James Stewart, M. D. Anderson Cancer Center at University of Texas |
| ClinicalTrials.gov Identifier: | NCT00104871 History of Changes |
| Other Study ID Numbers: | CDR0000415376, MDA-2004-0059, NCI-6132 |
| Study First Received: | March 3, 2005 |
| Last Updated: | March 17, 2010 |
| 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 |
|
Thyroid Neoplasms Head and Neck Neoplasms Thyroid Diseases Adenocarcinoma, Follicular Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |