A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma
PRIMARY OBJECTIVE:
I. Determine the efficacy of bortezomib, in terms of tumor response rate, in patients with
metastatic papillary or follicular thyroid cancer unresponsive to prior radioiodine therapy.
SECONDARY OBJECTIVE:
I. Determine the clinical activity of this drug, in terms of progression-free survival, in
patients treated with this drug.
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response rate assessed by RECIST
At 12 weeks
No
Steven Sherman
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
NCI-2009-00045
NCT00104871
December 2004
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Emory University | Atlanta, Georgia 30322 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
University of Colorado at Denver Health Sciences Center | Denver, Colorado 80045 |
Dana-Farber Harvard Cancer Center | Boston, Massachusetts 02115 |