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

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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non Small Cell Lung
Interventions Drug: vorinostat
Drug: bortezomib
Enrollment 18
Recruitment Details Recruitment occurred during 2/16/2008 and 03/09/2010.
Pre-assignment Details  
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description

Vorinostat 400 mg + Bortezomib 1.3 mg/m2

vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle

bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description

Vorinostat 400 mg + Bortezomib 1.3 mg/m2

vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle

bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
57
(45 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
9
  50.0%
Male
9
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.6%
White
17
  94.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
Histology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Adenocarcinoma 9
Squamous Cell 2
NSCLC, NOS 7
Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
0 5
1 12
2 1
[1]
Measure Description: Assigned following the Eastern Cooperative Oncology Group (ECOG) scale. Scores range from 0 (fully active) to 5 (dead).
Disease Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Metastatic 16
Recurrent 2
Brain Metastases 6
[1]
Measure Description: Disease stage per American Joint Committee on Cancer (AJCC) Lung Cancer Staging
Prior first-line systemic therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Paclitaxel/Platinum 10
Paclitaxel/Platinum/Bevacizumab 2
Paclitaxel/Platinum/Investigational Drug 2
Pemetrexed/Platinum 3
Vinorelbine/Platinum 1
Response to first-line therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Partial response 7
Stable disease 4
Progressive disease 6
Not reported 1
Prior second-line systemic therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Pemetrexed 10
Pemetrexed/Investigational drug 1
Docetaxel/Investigational drug 1
Erlotinib 4
Platinum doublets 2
Response to second-line therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Partial response 1
Stable disease 3
Progressive disease 13
Not reported 1
Prior thoracic radiation therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
6
1.Primary Outcome
Title Three-month Progression-free Survival
Hide Description 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."
Time Frame Three-months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:

Vorinostat 400 mg + Bortezomib 1.3 mg/m2

vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle

bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

Overall Number of Participants Analyzed 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.1
(0.8 to 25.6)
2.Secondary Outcome
Title Response Rate
Hide Description 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.
Time Frame Until disease progression, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:

Vorinostat 400 mg + Bortezomib 1.3 mg/m2

vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle

bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
Partial response 0
Stable disease 5
Progressive disease 13
3.Secondary Outcome
Title Median Overall Survival
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:

Vorinostat 400 mg + Bortezomib 1.3 mg/m2

vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle

bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: months
4.7
(3.2 to 8.6)
4.Secondary Outcome
Title Toxicity
Hide Description Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time Frame 30 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:

Vorinostat 400 mg + Bortezomib 1.3 mg/m2

vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle

bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
Thrombocytopenia Grade 3 7
Thrombocytopenia Grade 4 1
Lymphopenia Grade 3 3
Fatigue Grade 3 4
Fatigue Grade 4 1
Vomiting Grade 3 2
Dizziness Grade 3 2
Syncope Grade 3 2
Neuropathy Grade 3 2
Hyponatremia Grade 3 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description

Vorinostat 400 mg + Bortezomib 1.3 mg/m2

vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle

bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

All-Cause Mortality
Vorinostat + Bortezomib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vorinostat + Bortezomib
Affected / at Risk (%)
Total   8/18 (44.44%) 
Blood and lymphatic system disorders   
Lymphopenia  1/18 (5.56%) 
Platelets  1/18 (5.56%) 
Cardiac disorders   
Pericardial effusion (non-malignant)  1/18 (5.56%) 
Pericarditis  1/18 (5.56%) 
Gastrointestinal disorders   
Fistula, esophagus  1/18 (5.56%) 
General disorders   
Failure to thrive  1/18 (5.56%) 
Fatigue  1/18 (5.56%) 
Systemic inflammatory response syndrome  1/18 (5.56%) 
Metabolism and nutrition disorders   
Hypoalbuminemia  1/18 (5.56%) 
Hyponatremia  2/18 (11.11%) 
Nervous system disorders   
Confusion  1/18 (5.56%) 
Dizziness  1/18 (5.56%) 
Neuropathy, motor  1/18 (5.56%) 
Psychosis  1/18 (5.56%) 
Syncope  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  2/18 (11.11%) 
Hypoxia  2/18 (11.11%) 
Pleural effusion (non-malignant)  1/18 (5.56%) 
Vascular disorders   
Thrombosis/Thrombus/Embolism  1/18 (5.56%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vorinostat + Bortezomib
Affected / at Risk (%)
Total   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Abigail Mapes, Thoracic Oncology Research Program Manager
Organization: University of Wisconsin
Phone: (608) 262-8158
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00798720     History of Changes
Other Study ID Numbers: H-2008-0229
CO08502
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: April 28, 2016
Results First Posted: November 21, 2016
Last Update Posted: November 21, 2016