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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: Merck Sharp & Dohme Corp.; Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib; Vorinostat

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
• 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