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A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma

Phase 2
18 Years
Open (Enrolling)
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

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Trial Information

A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma


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.


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.

Inclusion Criteria:

- ECOG 0-2 OR Karnofsky 60-100%

- Platelet count >= 100,000/mm^3

- Absolute neutrophil count >= 1,500/mm^3

- WBC >= 3,000/mm^3

- AST and 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate assessed by RECIST

Outcome Time Frame:

At 12 weeks

Safety Issue:


Principal Investigator

Steven Sherman

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

Related Keywords:

  • 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
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Adenocarcinoma, Follicular



Cleveland Clinic Foundation Cleveland, Ohio  44195
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Emory University Atlanta, Georgia  30322
M D Anderson Cancer Center Houston, Texas  77030
Lombardi Comprehensive Cancer Center at Georgetown University Washington, District of Columbia  20057
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195
University of Colorado at Denver Health Sciences Center Denver, Colorado  80045
Dana-Farber Harvard Cancer Center Boston, Massachusetts  02115