Phase IB Study of Lenalidomide (Revlimid®) With Liposomal Doxorubicin (Doxil®) and Bevacizumab (Avastin®) for Patients With Platinum Resistant Ovarian Cancer.
The combination of Doxil with Avastin has several aspects of interest to ovarian cancer
treatment: 1) independent single-agent activity, 2) enhanced localization of Doxil is
possible tumoral interstitial pressure via increased half-life (if liposomal egress is
diminished) and decreased , 3) improved Doxil distribution, and 4) likely favorable
toxicity profile since Doxil's only common problematic toxicity is to the skin
(palmar-plantar erythrodysesthesia or PPE). Lenalidomide has also antiangiogenic properties,
with a different mechanism of action than Avastin. Given the preliminary results of the
effect of the combination of Doxil with Avastin, showing an increase in progression-free
survival, we are interested in using a new thalidomide analog to maximize the angiogenic
inhibition. This study will test the feasibility of combining all 3 drugs, and gather
preliminary data on the potential activity of the combination in patients with platinum
resistant/refractory ovarian cancer.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of the 3 drug combination and recommend a dose for phase II studies.
Teresa Rutledge, MD
University of New Mexico
United States: Institutional Review Board
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|