Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma
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.
Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Suberoylanilide Hydroxamic Acid and Bortezomib in Advanced Soft Tissue Sarcomas|
- Confirmed response rate defined as completer response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The distribution of time to progression will be estimated using the method of Kaplan-Meier. Estimates of time to progression, such as 3 and 6 month progression-free rates will be provided.
- Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Duration of response [ Time Frame: Date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date of progression is documented, assessed up to 2 years ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, assessed up to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (vorinostat, bortezomib)
Patients receive vorinostat PO QD once daily on days 1-14. Patients also receive bortezomib 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.
Other Names:Drug: bortezomib
I. To determine the objective response rate in patients with advanced soft tissue sarcoma treated with vorinostat and bortezomib.
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.
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.)
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287-8936|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Steven Attia||Mayo Clinic|