This trial is active, not recruiting.

Condition carcinoma, non small cell lung
Treatments vorinostat, bortezomib
Phase phase 2
Targets HDAC, proteasome
Sponsor University of Wisconsin, Madison
Collaborator Millennium Pharmaceuticals, Inc.
Start date December 2008
End date October 2012
Trial size 33 participants
Trial identifier NCT00798720, CO08502, H-2008-0229


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Vorinostat 400 mg + Bortezomib 1.3 mg/m2
vorinostat SAHA
400 mg by mouth once daily for days 1-14 of each 21 day cycle
bortezomib PS341
1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

Primary Outcomes

Three-month progression-free survival
time frame: Three-months post-treatment

Secondary Outcomes

Response rate
time frame: Until disease progression
Median overall survival
time frame: 5 years
time frame: 30 days post-treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Vorinostat (SAHA, Zolinza) and Bortezomib (PS341, Velcade) as Third-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
Principal investigator Tien Hoang, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.