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. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Administered IV at the dose of 1.3 mg/m\^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).
University of Colorado at Denver Health Sciences Center
Aurora, Colorado, United States
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Harvard Cancer Center
Boston, Massachusetts, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
M D Anderson Cancer Center
Houston, Texas, United States
Objective Tumor Response Rate Assessed by RECIST
Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: Baseline to 12 weeks
Participant Tumor Response Assessed by RECIST
Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))
Progression-free Survival Assessed by RECIST
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: At 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.