Randomized phase III study of intravenous (IV) paclitaxel and cisplatin vs. IV paclitaxel, intraperitoneal (IP) cisplatin and IP paclitaxel in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 172).

Trial ID #	GOG-172
Phase	III
Drug Class	Chemotherapy, Chemotherapy
Drug Name	Cisplatin, Paclitaxel
Alternate Drug Names	CACP, cis-DDP, cis-platinum, CDDP, Platinol, Abiplatin , Blastolem , Briplatin , Cisplatyl , Citoplatino , Citosin , Lederplatin , Metaplatin , Neoplatin , Placis, Platamine , Platiblastin , Platiblastin-S , Platinex , Platiran, Platistin, Platosin, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL
Drugs in Trial	Cisplatin, Paclitaxel
Eligible Participant	Newly diagnosed stage III ovarian cancer (optimally debulked)
Patients Enrolled	429
Therapy Setting	First-line
Study Design	Randomized
Endpoints	PFS, OS, evaluated per RECIST
Efficacy	CisPt+Pac (IV) vs CisPt+Pac (IP): PFS: 18.3 vs 23.8 months, RR: 0.80 (0.64-1.00, p=0.05) OS: 49.7 vs 65.6 months, RR: 0.75 (0.58-0.97, p=0.03)
Clinically Significant Adverse Events	CisPt+Pac (IV) vs CisPt+Pac (IP): Grade 3-4 AE: leukopenia (64 vs 76%), GI events (24 vs 46%), neurologic events (9 vs 19%), infection (6 vs 16%), fatigue (4 vs 18%), metabolic events (7 vs 27%), decreased platelet counts (4 vs 12%), pain (1 vs 11%)
Conclusion	PFS and OS increased with IP treatment in optimally debulked stage III patients, but IP had more severe AEs
Reference	Armstrong DK et al. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. NEJM (2006) 354(1):34-43 https://www.ncbi.nlm.nih.gov/pubmed/16394300