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

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Non Small Cell Lung

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Trial Information

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

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Three-month progression-free survival

Outcome Time Frame:

Three-months post-treatment

Safety Issue:


Principal Investigator

Tien Hoang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

June 2013

Related Keywords:

  • Carcinoma, Non Small Cell Lung
  • non small cell lung cancer
  • HDAC
  • proteasome inhibitor
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms