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Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00937495
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : November 21, 2013
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions Drug: vorinostat
Drug: bortezomib
Enrollment 16
Recruitment Details Sixteen patients were accrued to this study from June 2009 through July 2010.
Pre-assignment Details One participant received commercial drug instead of study drug and was deemed a violation. Another participant did not have a post baseline measurement scan and by protocol is not evaluable for the primary endpoint. These patients were excluded from the primary endpoint analysis. Therefore, 14 participants were evaluated for each endpoint.
Arm/Group Title Treatment (Vorinostat, Bortezomib)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 16
Completed 14
Not Completed 2
Reason Not Completed
Protocol Violation             2
Arm/Group Title Treatment (Vorinostat, Bortezomib)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
62
(34 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
11
  68.8%
Male
5
  31.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Confirmed Tumor Responses
Hide Description

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.

Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Vorinostat, Bortezomib)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0
Partial Response (PR) 0
2.Secondary Outcome
Title Progression Free Survival
Hide Description 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.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Vorinostat, Bortezomib)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 14
Median (95% Confidence Interval)
Unit of Measure: months
1.5
(1.3 to 2.9)
3.Secondary Outcome
Title Overall Survival
Hide Description The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame Time from registration to death due to any cause, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Vorinostat, Bortezomib)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 14
Median (95% Confidence Interval)
Unit of Measure: months
16.4 [1] 
(9.4 to NA)
[1]
The upper bound of the 95% confidence interval could not be estimated due to an insufficient number of events.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Vorinostat, Bortezomib)
Hide Arm/Group Description 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.
All-Cause Mortality
Treatment (Vorinostat, Bortezomib)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment (Vorinostat, Bortezomib)
Affected / at Risk (%) # Events
Total   6/16 (37.50%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  1/16 (6.25%)  2
Gastrointestinal disorders   
Diarrhea  1  3/16 (18.75%)  3
Nausea  1  1/16 (6.25%)  1
Vomiting  1  2/16 (12.50%)  2
General disorders   
Fatigue  1  1/16 (6.25%)  1
Investigations   
INR increased  1  1/16 (6.25%)  1
Platelet count decreased  1  3/16 (18.75%)  5
Metabolism and nutrition disorders   
Anorexia  1  1/16 (6.25%)  1
Dehydration  1  1/16 (6.25%)  1
Nervous system disorders   
Depressed level of consciousness  1  1/16 (6.25%)  1
Syncope  1  1/16 (6.25%)  1
Psychiatric disorders   
Confusion  1  1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
Erythema multiforme  1  1/16 (6.25%)  1
Vascular disorders   
Hypotension  1  1/16 (6.25%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Vorinostat, Bortezomib)
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  12/16 (75.00%)  35
Eye disorders   
Optic nerve edema  1  1/16 (6.25%)  1
Gastrointestinal disorders   
Constipation  1  1/16 (6.25%)  1
Diarrhea  1  12/16 (75.00%)  35
Dyspepsia  1  1/16 (6.25%)  1
Ear, nose and throat examination abnormal  1  1/16 (6.25%)  2
Flatulence  1  1/16 (6.25%)  2
Intra-abdominal hemorrhage  1  1/16 (6.25%)  1
Nausea  1  14/16 (87.50%)  35
Oral hemorrhage  1  2/16 (12.50%)  2
Upper gastrointestinal hemorrhage  1  1/16 (6.25%)  2
Vomiting  1  11/16 (68.75%)  18
General disorders   
Chills  1  1/16 (6.25%)  1
Edema limbs  1  2/16 (12.50%)  4
Fatigue  1  15/16 (93.75%)  48
Infections and infestations   
Mucosal infection  1  1/16 (6.25%)  1
Investigations   
Alanine aminotransferase increased  1  1/16 (6.25%)  1
Aspartate aminotransferase increased  1  5/16 (31.25%)  6
Bilirubin increased  1  1/16 (6.25%)  1
Creatinine increased  1  1/16 (6.25%)  1
Leukocyte count decreased  1  9/16 (56.25%)  11
Neutrophil count decreased  1  1/16 (6.25%)  1
Platelet count decreased  1  13/16 (81.25%)  33
Metabolism and nutrition disorders   
Anorexia  1  9/16 (56.25%)  29
Dehydration  1  2/16 (12.50%)  2
Musculoskeletal and connective tissue disorders   
Muscle weakness  1  1/16 (6.25%)  1
Muscle weakness lower limb  1  1/16 (6.25%)  1
Nervous system disorders   
Dizziness  1  3/16 (18.75%)  9
Peripheral motor neuropathy  1  3/16 (18.75%)  5
Peripheral sensory neuropathy  1  5/16 (31.25%)  18
Syncope  1  1/16 (6.25%)  1
Psychiatric disorders   
Insomnia  1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/16 (6.25%)  3
Dyspnea  1  2/16 (12.50%)  3
Skin and subcutaneous tissue disorders   
Alopecia  1  1/16 (6.25%)  1
Dry skin  1  1/16 (6.25%)  1
Rash desquamating  1  1/16 (6.25%)  2
Vascular disorders   
Hypotension  1  1/16 (6.25%)  1
Thrombosis  1  1/16 (6.25%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Attia, D.O.
Organization: University of Wisconsin
EMail: sa2@medicine.wisc.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00937495    
Other Study ID Numbers: NCI-2011-03810
MC0778
CDR0000646715
MAYO-MC0778
N01CM62205 ( U.S. NIH Grant/Contract )
First Submitted: July 10, 2009
First Posted: July 13, 2009
Results First Submitted: September 11, 2013
Results First Posted: November 21, 2013
Last Update Posted: May 14, 2014