Status:
COMPLETED
Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Merck Sharp & Dohme LLC
Conditions:
Carcinoma, Non Small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 mol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00798720
Start Date
December 1 2008
End Date
October 1 2012
Last Update
December 13 2019
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