Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer

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: NCT00798720
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : November 21, 2016
Last Update Posted : November 21, 2016
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE November 25, 2008
First Posted Date  ICMJE November 26, 2008
Results First Submitted Date April 28, 2016
Results First Posted Date November 21, 2016
Last Update Posted Date November 21, 2016
Study Start Date  ICMJE December 2008
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
Three-month Progression-free Survival [ Time Frame: Three-months post-treatment ]
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions."
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
Three-month Progression-free Survival [ Time Frame: Three-months post-treatment ]
Change History Complete list of historical versions of study NCT00798720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • Response Rate [ Time Frame: Until disease progression, up to 2 years ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI, CT, or chest x-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.
  • Median Overall Survival [ Time Frame: 5 years ]
  • Toxicity [ Time Frame: 30 days post-treatment ]
    Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
  • Response Rate [ Time Frame: Until disease progression ]
  • Median Overall Survival [ Time Frame: 5 years ]
  • Toxicity [ Time Frame: 30 days post-treatment ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer
Official Title  ICMJE Phase II Study of Vorinostat (SAHA, Zolinza) and Bortezomib (PS341, Velcade) as Third-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy) and tolerability of this regimen.
Detailed Description Current treatment for non-small cell lung cancer (NSCLC) remains inadequate. Vorinostat is a novel agent that inhibits the enzymatic activity of histone deacetylases (HDACs). Bortezomib is a small molecule proteasome inhibitor. Preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of NSCLC
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non Small Cell Lung
Intervention  ICMJE
  • Drug: vorinostat
    400 mg by mouth once daily for days 1-14 of each 21 day cycle
    Other Names:
    • SAHA
    • Zolinza
  • Drug: bortezomib
    1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle
    Other Names:
    • PS341
    • Velcade
Study Arms Experimental: Vorinostat + Bortezomib
Vorinostat 400 mg + Bortezomib 1.3 mg/m2
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 29, 2016)
18
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2008)
33
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically/histologically confirmed NSCLC
  • Advance NSCLC (stage IIIB w/ effusion, stage IV, or recurrent disease)
  • Measurable disease
  • Two prior systemic anti-cancer (cytotoxic or biologic) regimens for advanced/metastatic disease, including one (1) platinum-based chemotherapy
  • Prior treatment allowed if side effects have resolved and 3 weeks has passed since last dose of treatment (1 week for palliative radiation therapy)
  • ECOG performance status 0, 1, or 2
  • Patients with brain metastases are allowed, if clinically stable after treatment
  • Normal liver, kidney, and marrow function
  • 18 years of age or older
  • Negative pregnancy test for women of child-bearing potential.
  • Life expectancy 3 months or more
  • No concurrent use of other antitumor agents

Exclusion Criteria:

  • Prior therapy with vorinostat, HDAC inhibitors, or bortezomib
  • Pre-existing neuropathy grade >/= 2
  • Myocardial infarction within 6 months prior to enrollment or have NY Heart Association Class III or Class IV heart failure
  • Have taken valproic acid </= 4 weeks prior to enrollment
  • Previous or current malignancies of other histologies within the past 5 years, except cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
  • Hypersensitivity to bortezomib, boron, or mannitol
  • Serious medical or psychiatric illness likely to interfere with participation in the clinical study
  • Pregnant women
  • HIV positive patients
  • Hepatitis infection (HCV or HBV) patients
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00798720
Other Study ID Numbers  ICMJE H-2008-0229
CO08502
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • Millennium Pharmaceuticals, Inc.
  • Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Tien Hoang, M.D. University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date September 2016

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