Back to resultsBortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
Primary Purpose
Insular Thyroid Cancer, Recurrent Thyroid Cancer, Stage II Follicular Thyroid Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Insular Thyroid Cancer focused on measuring National Thyroid Cancer Treatment Cooperative Study Group, NTCTCSG, bortezomib, velcade, metastatic differentiated thyroid carcinoma, Differentiated thyroid carcinoma, follicular epithelial thyroid cells, papillary, oxyphilic cell, Hurthle cell, insular cell, columnar cell, tall cell
Eligibility Criteria
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
Sites / Locations
- University of Colorado at Denver Health Sciences Center
- Lombardi Comprehensive Cancer Center at Georgetown University
- Emory University
- Massachusetts General Hospital Cancer Center
- Dana-Farber Harvard Cancer Center
- Cleveland Clinic Foundation
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bortezomib
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00104871
First Posted
March 3, 2005
Last Updated
November 30, 2018
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00104871
Brief Title
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
Official Title
A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insular Thyroid Cancer, Recurrent Thyroid Cancer, Stage II Follicular Thyroid Cancer, Stage II Papillary Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Papillary Thyroid Cancer
Keywords
National Thyroid Cancer Treatment Cooperative Study Group, NTCTCSG, bortezomib, velcade, metastatic differentiated thyroid carcinoma, Differentiated thyroid carcinoma, follicular epithelial thyroid cells, papillary, oxyphilic cell, Hurthle cell, insular cell, columnar cell, tall cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bortezomib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
LDP 341, MLN341, VELCADE
Intervention Description
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).
Primary Outcome Measure Information:
Title
Objective Tumor Response Rate Assessed by RECIST
Description
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
Title
Participant Tumor Response Assessed by RECIST
Description
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))
Secondary Outcome Measure Information:
Title
Progression-free Survival Assessed by RECIST
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Sherman
Organizational Affiliation
The University of Texas MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado at Denver Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Harvard Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
The University of Texas MD Anderson Cancer Center official website
Learn more about this trial
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
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