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Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma

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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)

Tracking Information
First Submitted Date  ICMJE July 10, 2009
First Posted Date  ICMJE July 13, 2009
Results First Submitted Date  ICMJE September 11, 2013
Results First Posted Date  ICMJE November 21, 2013
Last Update Posted Date May 14, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2013)
Confirmed Tumor Responses [ Time Frame: Up to 2 years ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2009)
Objective response rate (complete response or partial response)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2013)
  • Progression Free Survival [ Time Frame: Up to 2 years ]
    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 ]
    The distribution of survival time will be estimated using the method of Kaplan-Meier.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2009)
  • Adverse events
  • Time to progression
  • Overall survival
  • Duration of response
  • Time to treatment failure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma
Official Title  ICMJE A Phase II Study of Suberoylanilide Hydroxamic Acid and Bortezomib in Advanced Soft Tissue Sarcomas
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.)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
Intervention  ICMJE
  • Drug: vorinostat
    400 mg given PO
    Other Names:
    • L-001079038
    • SAHA
    • suberoylanilide hydroxamic acid
    • Zolinza
  • Drug: bortezomib
    1.3 mg/m^2 given IV
    Other Names:
    • LDP 341
    • MLN341
    • VELCADE
Study Arms  ICMJE 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.
Interventions:
  • Drug: vorinostat
  • Drug: bortezomib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2013)
16
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2009)
45
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced, unresectable, or metastatic soft tissue sarcoma (STS)
  • Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension as >= 2 cm by conventional techniques OR >= 1 cm by spiral computed tomography (CT) scan
  • No small round cell tumors, including the following:

    • Primitive neuroectodermal tumor
    • Rhabdomyosarcoma
    • Ewing sarcoma
    • Osteosarcoma
  • No known active and/or untreated brain metastases and/or brain metastases requiring ongoing therapy (e.g., corticosteroids)

    • Treated, inactive brain metastases not requiring ongoing therapy allowed provided the brain metastases have been stable for >= 1 month as assessed by intracranial imaging AND there is no indication of increased vascularity of the treated metastases within 14 days before study entry as assessed by magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Life expectancy >= 12 weeks
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Total bilirubin normal
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance >= 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to take oral medication
  • No peripheral neuropathy >= grade 2
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia or myocardial infarction within the past 6 months
    • Psychiatric illness and/or social situation that would limit compliance with study requirements
  • No history of Torsades de Pointes
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat or bortezomib
  • No more than 1 prior systemic treatment for advanced STS, including investigational agents

    • Adjuvant therapy is not considered a systemic regimen
  • More than 2 weeks since prior valproic acid
  • More than 4 weeks since prior and no concurrent chemotherapy (> 6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered

    • Radiotherapy to bone metastasis within the past 2 weeks allowed provided there is active non-bone disease outside the radiation port
  • No prior radiotherapy to >= 33% of the bone marrow
  • No prior vorinostat or bortezomib
  • No concurrent category I medications that are generally accepted to have a risk of causing Torsades de Pointes, including any of the following:

    • Quinidine, procainamide, disopyramide
    • Amiodarone, sotalol, ibutilide, dofetilide
    • Erythromycin, clarithromycin
    • Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
  • No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
  • No other concurrent investigational agents for the primary malignancy
  • No other concurrent anticancer therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Australia,   Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT00937495
Other Study ID Numbers  ICMJE NCI-2011-03810
MC0778
CDR0000646715
MAYO-MC0778
N01CM62205 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Cancer Institute (NCI)
Original Responsible Party Howard H. Bailey, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Current Study Sponsor  ICMJE National Cancer Institute (NCI)
Original Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Attia Mayo Clinic
PRS Account National Cancer Institute (NCI)
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP