Expired Study
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Houston, Texas 77030


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

NCI-2009-00045


NCT ID:

NCT00104871


Secondary ID:

2004-0059


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Steven Sherman
Principal Investigator
The University of Texas MD Anderson Cancer Center

Study Dates

Start Date:December 2004
Completion Date:April 2014
Completion Type:Actual
Primary Completion Date:May 2010
Primary Completion Type:Actual
Verification Date:November 2018
Last Changed Date:November 30, 2018
First Received Date:March 3, 2005
First Results Date:November 20, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Progression-free Survival Assessed by RECIST
Time Frame:At 6 months
Safety Issues:False
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
Outcome Type:Primary Outcome
Measure:Participant Tumor Response Assessed by RECIST
Time Frame:Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))
Safety Issues:False
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): &g
Outcome Type:Primary Outcome
Measure:Objective Tumor Response Rate Assessed by RECIST
Time Frame:Baseline to 12 weeks
Safety Issues:False
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 Crite

Study Interventions

Intervention Type:Drug
Name:Bortezomib
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).
Arm Name:Bortezomib
Other Name:LDP 341

Study Arms

Study Arm Type:Experimental
Arm Name:Bortezomib
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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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