Phase I Study of Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Since the regimen of bevacizumab, carboplatin and paclitaxel has become a standard regimen
for the treatment of advanced non-squamous NSCLC, new studies in this patient population
will have to include this as a reference arm. Addition of a fourth anti-cancer agent has
now become the new strategy to improve the outcome for advanced non-squamous NSCLC. Since
the regimen of Vorinostat, Carboplatin and Paclitaxel is already in advanced stage of
development it is important to study the safety and tolerability of Vorinostat in
combination with the three-drug regimen of Bevacizumab, Carboplatin and Paclitaxel.
Therefore, we will evaluate Vorinostat when administered in combination with the regimen of
Carboplatin, Paclitaxel and Bevacizumab for patients with previously untreated advanced
non-small cell lung cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Establish the phase II recommended dose (P2RD) of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lung cancer.
Participants will be followed for survival, an expected average of two years.
An average of 2 years
Chandra P Belani, MD
Penn State College of Medicine
United States: Institutional Review Board
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033|