Phase II study of cisplatin plus gemcitabine in platinum-resistant and platinum-refractory ovarian cancer

Trial ID #	Rose (2003) CisPt+Gem
Phase	II
Drug Class	Chemotherapy
Drug Name	Cisplatin
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
Drugs in Trial	Cisplatin, Gemcitabine
Eligible Participant	Platinum resistant or refractory ovarian cancer
Patients Enrolled	36; median 2 prior platinum-based therapies (1-5) and median 3 prior non-platinum-based therapies (0-6)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, PFS, OS, evaluated per RECIST or CA125
Efficacy	ORR: 42.9% (4CR, 11PR, n=35) DCR: 68.6% (4CR, 11PR, 9SD, n=35) DoR: 11 months (4-14) PFS: 6 months (1-14) OS: 12 months
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: neutropenia (53%), leukopenia (44%), thrombocytopenia (36%), anemia (19%),
Conclusion	Cisplatin+gemcitabine is active in Pt-R and Pt-Rf patients ORR: 42.9% PFS: 6 months
Reference	Rose PG et al. Gemcitabine Reverses Cisplatin Resistance: Demonstration of Activity in Platinum- and Multidrug-Resistant Ovarian and Peritoneal Carcinoma. Gynecol Oncol (2003) 88: 17-21 https://www.ncbi.nlm.nih.gov/pubmed/12504621