Spots Global Cancer Trial Database for Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma

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Trial Identification

Brief Title: Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma

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

Study ID: NCT00937495

Conditions

Recurrent Adult Soft Tissue Sarcoma

Stage III Adult Soft Tissue Sarcoma

Stage IV Adult Soft Tissue Sarcoma

Interventions

vorinostat

bortezomib

Study Description

Brief 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.)