NCT00104871

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Bortezomib	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).

Timeline

• Start date: 2004-12-01
• Primary completion: 2010-05-01
• Completion: 2014-04-01
• First posted: 2005-03-04
• Last updated: 2018-12-19
• Results posted: 2014-06-25

Locations

9 sites across 1 country: United States