NCT00937495

Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma

A Phase II Study of Suberoylanilide Hydroxamic Acid and Bortezomib in Advanced Soft Tissue Sarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (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 giving vorinostat together with bortezomib works in treating patients with advanced soft tissue sarcoma. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the objective response rate in patients with advanced soft tissue sarcoma treated with vorinostat and bortezomib. SECONDARY OBJECTIVES: I. Characterize the toxicity of this regimen in these patients. II. Evaluate the progression-free survival and median overall survival of patients treated with this regimen. OUTLINE: Patients receive vorinostat orally (PO) once daily on days 1-14. Patients also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 6 months for up to 2 years. (As of Addendum 7, patient follow-up no longer required.)

Conditions

• Recurrent Adult Soft Tissue Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	vorinostat	400 mg given PO
DRUG	bortezomib	1.3 mg/m\^2 given IV

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-08-01
• Completion: 2011-06-01
• First posted: 2009-07-13
• Last updated: 2014-05-14
• Results posted: 2013-11-21

Locations

6 sites across 1 country: United States