Trial Outcomes & Findings for Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer (NCT NCT00798720)
NCT ID: NCT00798720
Last Updated: 2019-12-13
Results Overview
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."
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Three-months post-treatment
Results posted on
2019-12-13
Participant Flow
Recruitment occurred during 2/16/2008 and 03/09/2010.
Participant milestones
| Measure |
Vorinostat + Bortezomib
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 Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Vorinostat + Bortezomib
n=18 Participants
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
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
9 participants
n=5 Participants
|
|
Histology
Squamous Cell
|
2 participants
n=5 Participants
|
|
Histology
NSCLC, NOS
|
7 participants
n=5 Participants
|
|
Performance Status
0
|
5 participants
n=5 Participants
|
|
Performance Status
1
|
12 participants
n=5 Participants
|
|
Performance Status
2
|
1 participants
n=5 Participants
|
|
Disease Stage
Metastatic
|
16 participants
n=5 Participants
|
|
Disease Stage
Recurrent
|
2 participants
n=5 Participants
|
|
Disease Stage
Brain Metastases
|
6 participants
n=5 Participants
|
|
Prior first-line systemic therapy
Paclitaxel/Platinum
|
10 participants
n=5 Participants
|
|
Prior first-line systemic therapy
Paclitaxel/Platinum/Bevacizumab
|
2 participants
n=5 Participants
|
|
Prior first-line systemic therapy
Paclitaxel/Platinum/Investigational Drug
|
2 participants
n=5 Participants
|
|
Prior first-line systemic therapy
Pemetrexed/Platinum
|
3 participants
n=5 Participants
|
|
Prior first-line systemic therapy
Vinorelbine/Platinum
|
1 participants
n=5 Participants
|
|
Response to first-line therapy
Partial response
|
7 participants
n=5 Participants
|
|
Response to first-line therapy
Stable disease
|
4 participants
n=5 Participants
|
|
Response to first-line therapy
Progressive disease
|
6 participants
n=5 Participants
|
|
Response to first-line therapy
Not reported
|
1 participants
n=5 Participants
|
|
Prior second-line systemic therapy
Pemetrexed
|
10 participants
n=5 Participants
|
|
Prior second-line systemic therapy
Pemetrexed/Investigational drug
|
1 participants
n=5 Participants
|
|
Prior second-line systemic therapy
Docetaxel/Investigational drug
|
1 participants
n=5 Participants
|
|
Prior second-line systemic therapy
Erlotinib
|
4 participants
n=5 Participants
|
|
Prior second-line systemic therapy
Platinum doublets
|
2 participants
n=5 Participants
|
|
Response to second-line therapy
Partial response
|
1 participants
n=5 Participants
|
|
Response to second-line therapy
Stable disease
|
3 participants
n=5 Participants
|
|
Response to second-line therapy
Progressive disease
|
13 participants
n=5 Participants
|
|
Response to second-line therapy
Not reported
|
1 participants
n=5 Participants
|
|
Prior thoracic radiation therapy
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three-months post-treatmentProgression 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."
Outcome measures
| Measure |
Vorinostat + Bortezomib
n=18 Participants
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
|
|---|---|
|
Three-month Progression-free Survival
|
11.1 percentage of participants
Interval 0.8 to 25.6
|
SECONDARY outcome
Timeframe: Until disease progression, up to 2 yearsPer 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.
Outcome measures
| Measure |
Vorinostat + Bortezomib
n=18 Participants
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
|
|---|---|
|
Response Rate
Stable disease
|
5 participants
|
|
Response Rate
Partial response
|
0 participants
|
|
Response Rate
Progressive disease
|
13 participants
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Vorinostat + Bortezomib
n=18 Participants
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
|
|---|---|
|
Median Overall Survival
|
4.7 months
Interval 3.2 to 8.6
|
SECONDARY outcome
Timeframe: 30 days post-treatmentGraded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Outcome measures
| Measure |
Vorinostat + Bortezomib
n=18 Participants
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
|
|---|---|
|
Toxicity
Thrombocytopenia Grade 3
|
7 participants
|
|
Toxicity
Thrombocytopenia Grade 4
|
1 participants
|
|
Toxicity
Lymphopenia Grade 3
|
3 participants
|
|
Toxicity
Fatigue Grade 3
|
4 participants
|
|
Toxicity
Fatigue Grade 4
|
1 participants
|
|
Toxicity
Vomiting Grade 3
|
2 participants
|
|
Toxicity
Dizziness Grade 3
|
2 participants
|
|
Toxicity
Syncope Grade 3
|
2 participants
|
|
Toxicity
Neuropathy Grade 3
|
2 participants
|
|
Toxicity
Hyponatremia Grade 3
|
3 participants
|
Adverse Events
Vorinostat + Bortezomib
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vorinostat + Bortezomib
n=18 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.6%
1/18
|
|
Blood and lymphatic system disorders
Platelets
|
5.6%
1/18
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
5.6%
1/18
|
|
Cardiac disorders
Pericarditis
|
5.6%
1/18
|
|
General disorders
Failure to thrive
|
5.6%
1/18
|
|
General disorders
Fatigue
|
5.6%
1/18
|
|
Gastrointestinal disorders
Fistula, esophagus
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18
|
|
Nervous system disorders
Confusion
|
5.6%
1/18
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18
|
|
Nervous system disorders
Neuropathy, motor
|
5.6%
1/18
|
|
Nervous system disorders
Psychosis
|
5.6%
1/18
|
|
Nervous system disorders
Syncope
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.6%
1/18
|
|
General disorders
Systemic inflammatory response syndrome
|
5.6%
1/18
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
5.6%
1/18
|
Other adverse events
Adverse event data not reported
Additional Information
Abigail Mapes, Thoracic Oncology Research Program Manager
University of Wisconsin
Phone: (608) 262-8158
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place