Phase II study of intraperitoneal submicron particle paclitaxel (SPP) plus IV carboplatin and paclitaxel in patients with epithelial ovarian cancersurgery

Gynecologic Oncology Reports

Kimberly Levinson¹  Alyson Marin²  Yi-Chun Lee³  S. Diane Yamada⁴  Gere diZerega⁵  Peter Mast⁵  Joan Walker⁶  Sally Mullany⁷  Maurie Markman⁸  David Scott Miller⁹  Katina Robison^1,10 

[1] Infants Hospital, 101 Dudley St, Providence, RI 02905, USA;Cancer Treatment Centers of America, 1331 E Wyoming Ave, Philadelphia, PA 19124, USA;Johns Hopkins Gynecologic Oncology at GBMC, 6569 Charles St 306, Towson, MD 21204, USA;SUNY DownState Medical Center, 450 Clarkson Ave, Brooklyn, NY 11203, USA;US Biotest Inc., 231 Bonetti Dr240, San Luis Obispo, CA 93401, USA;University of Chicago Medical Center, 5841 S Maryland Ave, Chicago, IL 60637, USA;University of Minnesota Medical Center, 2450 Riverside Ave, Minneapolis, MN 55454, USA;University of Oklahoma, Stephenson Cancer Center, 800 NE 10th St, Oklahoma City, OK 73104, USA;University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA;;Women &

关键词: Ovarian cancer;    Paclitaxel;    Intraperitoneal therapy;    NanoPac;    Submicron particle paclitaxel;   

DOI  :  

来源: DOAJ

【 摘 要 】

Submicron particles (~800 nm) of paclitaxel (SPP) contain 1–2 billion molecules of pure drug that release tumoricidal levels of paclitaxel over many weeks. This study compared two dose-levels of SPP instilled into the peritoneal cavity (IP) in 200 ml of saline post-cytoreductive surgery. Eligible patients with primary (n = 6) or recurrent (n = 4) epithelial ovarian cancer who underwent complete cytoreductive surgery were enrolled to receive a single instillation of IP SPP followed by standard IV carboplatin and paclitaxel. Endpoints were PFS and evaluation of treatment emergent adverse events. Clinical response was determined by symptoms, physical exams, CT scans, and serum CA-125 measurements. Of the 24 subjects screened, 10 were enrolled and received treatment: seven patients received 100 mg/m2 and three received 200 mg/m2. Seven subjects completed the 12-month follow-up period. Six patients were evaluable due to one subject who had unevaluable scans throughout the follow-up period and was thus excluded from PFS determination. Upon completion of planned chemotherapy post-SPP instillation, the PFS at 6 months was 66% (4/6) and at 12-months 66% (4/6) using RECIST 1.1. One subject had a complete response at the end of IV treatment but died (unrelated to study treatment) before PFS evaluation. There was one case of incision dehiscence and one case of vaginal cuff leakage after surgery. This pilot study supports further evaluation of IP SPP to treat peritoneal carcinomas.

【 授权许可】

Unknown