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, Gemcitabine
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, Gemzar
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

The combination of cisplatin+gemcitabine is active in platinum-resistant and platinum-refractory 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