Vorinostat in Combination With Palliative Radiotherapy for Patients With Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00821951
First received: January 8, 2009
Last updated: December 7, 2012
Last verified: December 2012
Results First Received: December 7, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer (NSCLC)
Interventions: Drug: Vorinostat
Radiation: Radiotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients at Yale New Haven Hospital were recruited for a dose escalation trial between 2009 and 2010. Eligibility criteria included a histologic diagnosis of NSCLC, and an indication for palliative thoracic radiation in patients with either metastatic disease or locally advanced disease that precluded potentially curative therapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
ECOG PS of 0 to 2, and adequate hematologic, hepatic, and renal function were required. Patients with prolonged QT syndrome or significant cardiovascular disease were excluded, as were patients with untreated brain metastases. Prior thoracic radiation was permitted as long as a treatment field could be designed without significant overlap

Reporting Groups
  Description
Vorinostat and Radiotherapy

Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction

Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.


Participant Flow:   Overall Study
    Vorinostat and Radiotherapy  
STARTED     17  
COMPLETED     12  
NOT COMPLETED     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vorinostat and Radiotherapy

Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction

Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.


Baseline Measures
    Vorinostat and Radiotherapy  
Number of Participants  
[units: participants]
  17  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     12  
Age  
[units: years]
Mean ± Standard Deviation
  68.5  ± 8.2  
Gender  
[units: participants]
 
Female     9  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     17  



  Outcome Measures

1.  Primary:   The Primary Endpoint of the Study is to Establish the Maximum Tolerated Dose of Vorinostat When Given Concurrently With Palliative Radiation.   [ Time Frame: 1 Year ]

2.  Secondary:   Target Lesion Response   [ Time Frame: 1 Year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Vorinostat Modification of the DNA Damage Response in Patient Samples   [ Time Frame: 1 Year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Roy H Decker, MD PhD
Organization: Yale University
phone: 203 737-2758
e-mail: roy.decker@yale.edu


No publications provided


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00821951     History of Changes
Other Study ID Numbers: 0811004507
Study First Received: January 8, 2009
Results First Received: December 7, 2012
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board