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

NCT ID: NCT00798720

Last Updated: 2019-12-13

Basic Information

• 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

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

Conditions

Carcinoma, Non Small Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

SAHA; Zolinza; PS341; Velcade

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

Responsibility Role: SPONSOR

Principal Investigators

Tien Hoang, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

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