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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Recurrent Thyroid Cancer

Stage II Papillary Thyroid Cancer

Stage IV Follicular Thyroid Cancer

Insular Thyroid Cancer

Stage II Follicular Thyroid Cancer

Stage IV Papillary Thyroid Cancer

Treatments

Drug: Bortezomib

Study type

Interventional

Funder types

NIH

Identifiers

NCT00104871

2004-0059 (Other Identifier)

N01CM17003 (U.S. NIH Grant/Contract)

N01CM62202 (U.S. NIH Grant/Contract)

CDR0000415376 (Registry Identifier)

NCI-2009-00045

N01CM62203 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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