A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma
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.
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.
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
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|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|