Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

Phase 2

Completed

Conditions: Recurrent Thyroid Cancer
Stage II Papillary Thyroid Cancer
Stage IV Papillary Thyroid Cancer
Insular Thyroid Cancer
Stage II Follicular Thyroid Cancer
Stage IV Follicular Thyroid Cancer

Interventions: Drug: Bortezomib

Registration Number: NCT00104871

Lead Sponsor: National Cancer Institute (NCI)

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

The Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%
Platelet count >= 100,000/mm^3
Absolute neutrophil count >= 1,500/mm^3
White Blood Count (WBC) >= 3,000/mm^3
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =< 2.5 times upper limit of normal
Bilirubin normal
No symptomatic congestive heart failure
Creatinine normal OR creatinine clearance >= 60 mL/min
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No other uncontrolled illness
At least 4 weeks since prior chemotherapy
No more than 2 prior chemotherapy regimens
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 (dose =< 6,000 cGy)
At least 6 months since prior radioiodine therapy
No prior external radiotherapy to the measured tumor
Prior thyroidectomy allowed
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent anticancer therapy
Unresponsive to prior radioiodine therapy
Histologically confirmed differentiated thyroid cancer-papillary or follicular type, including, but not limited to, any of the following variants: hurthle cell (oxyphilic), insular, columnar cell, tall cell
Metastatic disease
At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
No prior radiotherapy to the only measurable lesion
No radioiodine uptake in the measured metastatic tumor by radioiodine scan (Note: Must have had >= 1 radioiodine scan since the last radioiodine treatment)
No known brain metastases

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bortezomib	Bortezomib	Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response Rate Assessed by RECIST	Baseline to 12 weeks	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.
Participant Tumor Response Assessed by RECIST	Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival Assessed by RECIST	At 6 months	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

Trial Locations

Locations (9): Lombardi Comprehensive Cancer Center at Georgetown University
🇺🇸
Washington, District of Columbia, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Massachusetts General Hospital Cancer Center
🇺🇸
Boston, Massachusetts, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of Colorado at Denver Health Sciences Center
🇺🇸
Aurora, Colorado, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States
Dana-Farber Harvard Cancer Center
🇺🇸
Boston, Massachusetts, United States
M D Anderson Cancer Center
🇺🇸
Houston, Texas, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States