| 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) |
| Clinically Significant Adverse Events | Serious AE: |
| Conclusion | Cisplatin+gemcitabine is active in Pt-R and Pt-Rf patients ORR: 42.9% |
| 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 |
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