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

NCT ID: NCT00798720

Last Updated: 2019-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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

Conditions

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Carcinoma, Non Small Cell Lung

Keywords

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non small cell lung cancer HDAC proteasome inhibitor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vorinostat + Bortezomib

Vorinostat 400 mg + Bortezomib 1.3 mg/m2

Group Type EXPERIMENTAL

vorinostat

Intervention Type DRUG

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

bortezomib

Intervention Type DRUG

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

Interventions

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vorinostat

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

Intervention Type DRUG

bortezomib

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

Intervention Type DRUG

Other Intervention Names

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SAHA Zolinza PS341 Velcade

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tien Hoang, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Countries

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United States

Other Identifiers

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H-2008-0229

Identifier Type: OTHER

Identifier Source: secondary_id

A534260

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\HEM-ONC

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00811

Identifier Type: REGISTRY

Identifier Source: secondary_id

CO08502

Identifier Type: -

Identifier Source: org_study_id