Clinical trial NCT00104871: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-03-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective Tumor Response Rate Assessed by RECIST
timeFrame: Baseline to 12 weeks
measure: Participant Tumor Response Assessed by RECIST
timeFrame: Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))
Secondary outcomes:
measure: Progression-free Survival Assessed by RECIST
timeFrame: At 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado at Denver Health Sciences Center
state: Colorado
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Harvard Cancer Center
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Steven Sherman
role: PRINCIPAL_INVESTIGATOR
References: