Vorinostat and Bortezomib as Third-Line Treatment in Advanced Non-Small Cell Lung Cancer

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, June 2009

First Received: November 25, 2008 Last Updated: June 3, 2009 History of Changes

Sponsors and Collaborators:	University of Wisconsin, Madison Millennium Pharmaceuticals, Inc. Merck
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00798720

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non Small Cell Lung	Drug: vorinostat Drug: bortezomib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Suberoylanilide hydroxamic acid Bortezomib

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Three-month progression-free survival [ Time Frame: Three-months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
Median overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	33
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 </= 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798720

Contacts

Contact: Cancer Connect

(800) 622-8922

Locations

United States, Wisconsin
University of Wisconsin - Madison	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect 800-622-8922

Sponsors and Collaborators

University of Wisconsin, Madison

Millennium Pharmaceuticals, Inc.

Merck

Investigators

Principal Investigator:

Tien Hoang, M.D.

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin, Madison ( Tien Hoang, M.D. )
Study ID Numbers:	H-2008-0229, CO08502
Study First Received:	November 25, 2008
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00798720 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

non small cell lung cancer
HDAC
proteasome inhibitor

Study placed in the following topic categories:

Anticarcinogenic Agents
Thoracic Neoplasms
Anti-Inflammatory Agents
Vorinostat
Bortezomib
Protease Inhibitors
Carcinoma
Respiratory Tract Diseases
Analgesics, Non-Narcotic

Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anticarcinogenic Agents
Thoracic Neoplasms
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Respiratory Tract Neoplasms
Neoplasms by Histologic Type

Bortezomib
Vorinostat
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Carcinoma
Neoplasms
Analgesics, Non-Narcotic
Lung Diseases
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009