Randomized Phase II Study of Vorinostat or Placebo in Combination With Carboplatin and Paclitaxel for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
I. To compare the response rate associated with the combination of vorinostat, carboplatin,
paclitaxel versus carboplatin, paclitaxel and placebo for patients with previously
untreated, advanced NSCLC.
I. To determine the time to progression and overall survival for the two regimens.
II. To assess the safety profile of the regimen of vorinostat, carboplatin and paclitaxel
for patients with advanced NSCLC.
III. To understand mechanistic aspects of drug effect by conducting correlative science
studies on peripheral blood, archived tumor tissue, and paired biopsies in consenting
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
gender and brain metastasis (present vs absent). Patients are randomized to 1 of 2 treatment
Arm I: Patients receive oral vorinostat (SAHA) once daily on days 1-14 and paclitaxel IV
over 3 hours and carboplatin IV over 30 minutes on day 3.
Arm II: Patients receive an oral placebo once daily on days 1-14 and paclitaxel and
carboplatin as in arm l.
In both arms, treatment repeats every 21 days for 4-6 courses in the absence of disease
progression or unacceptable toxicity.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data).
Up to 1 year
Beckman Research Institute
United States: Food and Drug Administration
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