Phase II Randomized Study of Vorinostat or Placebo in Combination With Carboplatin and Paclitaxel for Patients With Advanced Non-small Cell Lung Cancer
I. To compare progression-free survival associated with the combination of carboplatin,
paclitaxel and vorinostat versus carboplatin, paclitaxel and placebo for patients with
previously untreated, advanced NSCLC.
I. To determine the response rate, time to treatment failure, and overall survival for the
II. To assess the safety profile of the regimen of vorinostat, carboplatin and paclitaxel
for patients with advanced NSCLC.
III. To understand the mechanistic aspects of drug effect by conducting correlative science
studies on peripheral blood and archived tumor tissue.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes on
day 0. Patients also receive vorinostat orally (PO) once daily on days -2 to 2.
ARM II: Patients receive paclitaxel and carboplatin as in arm I. Patients also receive
placebo PO once daily on days -2 to 2.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, quarterly for 1
year, and then twice a year thereafter.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-free survival, defined as time from randomization to progression or death due to any cause
Up to 1 year
Beckman Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|City of Hope Medical Center||Duarte, California 91010|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|University of North Carolina||Chapel Hill, North Carolina 27599|
|Emory University||Atlanta, Georgia 30322|
|UC Davis Comprehensive Cancer Center||Sacramento, California 95817|
|Virginia Commonwealth University||Richmond, Virginia|
|University of Southern California||Los Angeles, California 90033|
|Penn State Milton S Hershey Medical Center||Hershey, Pennsylvania 17033|
|Illinois CancerCare-Peoria||Peoria, Illinois 61615|
|Saint John's Mercy Medical Center||Saint Louis, Missouri 63141|
|Southern Illinois University School of Medicine - Obstetrics and Oncology||Springfield, Illinois 62794|