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Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: March 3, 2005   Last Updated: July 21, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00104871
  Purpose

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: bortezomib
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response rate by RECIST at 12 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: December 2004
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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

  • 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.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  • Measurable 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
  • Unresponsive to prior radioiodine therapy

    • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal
  • Bilirubin normal

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy
  • No more than 2 prior chemotherapy regimens

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • 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

Surgery

  • Prior thyroidectomy allowed

Other

  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104871

Locations
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Bryan R. Haugen, MD     303-315-8443        
United States, Ohio
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: J. D. Brierley, MD     416-946-2124     james.brierly@rmp.uhn.on.ca    
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Steven I. Sherman, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M. D. Anderson Cancer Center at University of Texas ( David James Stewart )
Study ID Numbers: CDR0000415376, MDA-2004-0059, NCI-6132
Study First Received: March 3, 2005
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00104871     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II follicular thyroid cancer
stage IV follicular thyroid cancer
stage II papillary thyroid cancer
stage IV papillary thyroid cancer
insular thyroid cancer
recurrent thyroid cancer

Additional relevant MeSH terms:
Adenocarcinoma, Follicular
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Thyroid Neoplasms
Antineoplastic Agents
Bortezomib
Endocrine System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Carcinoma
Neoplasms
Neoplasms by Site
Therapeutic Uses
Head and Neck Neoplasms
Adenocarcinoma
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010