Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group Study.

Trial ID #	GOG-158
Phase	III
Drug Class	Chemotherapy, Chemotherapy, Chemotherapy
Drug Name	Carboplatin, Cisplatin, Paclitaxel
Alternate Drug Names	Paraplatin, Novoplatinum, 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	Carboplatin, Cisplatin, Paclitaxel
Eligible Participant	Newly diagnosed stage III ovarian cancer (optimally debulked)
Patients Enrolled	840
Therapy Setting	First-line
Study Design	Randomized
Endpoints	PFS, OS, evaluated per RECIST
Efficacy	CisPt+Pac vs CarboPt+Pac: PFS: 19.4 vs 20.7 months, RR: 0.88 (0.75-1.03, p=NS) OS: 48.7 vs 57.4 months, RR: 0.84 (0.70-1.02, p=NS)
Clinically Significant Adverse Events	CisPt+Pac vs CarboPt+Pac: Grade 3-4 AE: leukopenia (63 vs 59%), thrombocytopenia (5 vs 39%), granulocytopenia (93 vs 89%), GI events (23 vs 10%)
Conclusion	No PFS or OS difference between cisplatin+paclitaxel and carboplatin+paclitaxel in optimally debulked stage III patients
Reference	Ozols RF et al. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol (2003) 21(17):3194-200 https://www.ncbi.nlm.nih.gov/pubmed/12860964