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


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, PFS, OS, evaluated per RECIST or CA125


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%),


Cisplatin+gemcitabine is active in Pt-R and Pt-Rf patients

ORR: 42.9%
PFS: 6 months


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

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