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COMPLETEDPHASE2

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

Phase II Study of Vorinostat (SAHA, Zolinza) and Bortezomib (PS341, Velcade) as Third-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer

NCT00798720•University of Wisconsin, Madison

View on ClinicalTrials.gov

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 of this regimen.

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 molecule proteasome inhibitor. Preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of NSCLC

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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 \</= 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 Dates

Start Date

December 1, 2008

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

December 13, 2019

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non Small Cell Lung

Interventions

vorinostat

DRUG

bortezomib

DRUG

Locally Advanced NSCLC Hyperfractionated RT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Locally Advanced NSCLC Hyperfractionated RT

Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

Efficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer