A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy (NCIC OV15)

Trial ID #	NCT00102414; NCIC OV15
Phase	III
Drug Class	Chemotherapy, Chemotherapy
Drug Name	Carboplatin, Gemcitabine
Alternate Drug Names	Paraplatin, Novoplatinum, Gemzar
Drugs in Trial	Carboplatin, Gemcitabine
Eligible Participant	Platinum sensitive ovarian cancer at recurrence following first-line platinum-based chemotherapy
Patients Enrolled	356
Therapy Setting	Recurrence
Study Design	Open-Label, Randomized
Endpoints	ORR, PFS, OS, evaluated per RECIST
Efficacy	CarboPt+Gem vs CarboPt: ORR: 47.2 vs 30.9% (p=0.0016) PFS: 8.6 vs 5.8 months, HR: 0.72 (0.58-0.90, p=0.003) OS: 18.0 vs 17.3 months, HR: 0.96 (0.75-1.23, p=0.735) (71% maturity, not powered for OS)
Clinically Significant Adverse Events	CarboPt+Gem vs CarboPt: Serious AE: none Grade 3-4 AE: anemia (27.4 vs 9.0%), neutropenia (70.3 vs 12.0%), thrombocytopenia (34.9 vs 11.4%), RBC tranfusions (27.0 vs 6.7%), G-CSF/GM-CSF use (23.6 vs 10.1%)
Conclusion	Improved PFS with addition of gemcitabine
Reference	Pfisterer J et al. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol (2006) 24(20):4699-707 https://www.ncbi.nlm.nih.gov/pubmed/16966687