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

• ClinicalTrials.gov Identifier: NCT00104871
• Recruitment Status: Completed
• First Posted: March 4, 2005
• Results First Posted: June 25, 2014
• Last Update Posted: December 19, 2018
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Cancer Institute (NCI)

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

Condition or disease	Intervention/treatment	Phase
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	Drug: Bortezomib	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma
• Study Start Date: December 2004
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Bortezomib; 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).; Other Names: LDP 341; MLN341; VELCADE

Outcome Measures

Primary Outcome Measures :

1. Objective Tumor Response Rate Assessed by RECIST [ Time Frame: 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.
2. Participant Tumor Response Assessed by RECIST [ Time Frame: 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 :

1. Progression-free Survival Assessed by RECIST [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Colorado

University of Colorado at Denver Health Sciences Center

Aurora, Colorado, United States, 80045

United States, District of Columbia

Lombardi Comprehensive Cancer Center at Georgetown University

Washington, District of Columbia, United States, 20057

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Dana-Farber Harvard Cancer Center

Boston, Massachusetts, United States, 02115

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44195

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States, 43210

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Steven Sherman; The University of Texas MD Anderson Cancer Center

More Information

Additional Information:

The University of Texas MD Anderson Cancer Center official website 

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00104871
• Other Study ID Numbers: NCI-2009-00045; 2004-0059 ( Other Identifier: UT MD Anderson Cancer Center ); N01CM62202 ( U.S. NIH Grant/Contract ); N01CM62203 ( U.S. NIH Grant/Contract ); N01CM17003 ( U.S. NIH Grant/Contract ); CDR0000415376 ( Registry Identifier: PDQ (Physician Data Query) )
• First Posted: March 4, 2005
• Results First Posted: June 25, 2014
• Last Update Posted: December 19, 2018
• Last Verified: November 2018

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thyroid Neoplasms; Thyroid Cancer, Papillary; Adenocarcinoma, Follicular; Thyroid Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Adenocarcinoma; Bortezomib; Antineoplastic Agents