Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma
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 Tumor Responses [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
The number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.
- Progression Free Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Progression-free survival is defined as the time from registration to the time of progression or death, whichever comes first. The distribution and median of progression-free survival times will be estimated using the method of Kaplan-Meier.
- Overall Survival [ 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.
|Study Start Date:||June 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (vorinostat, bortezomib)
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 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.
400 mg given PO
Other Names:Drug: bortezomib
1.3 mg/m^2 given IV
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.)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937495
|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|