| Trial ID # | UMIN000004449 |
| Phase | II |
| Drug Class | Chemotherapy |
| Drug Name | Gemcitabine |
| Alternate Drug Names | Gemzar |
| Drugs in Trial | Irinotecan, Gemcitabine |
| Eligible Participant | Platinum resistant or refractory ovarian cancer with ≥ 2 prior platinum regimens; no primary platinum resistant or refractory |
| Patients Enrolled | 25, median 2 prior therapies |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, PFS, OS, evaluated per RECIST |
| Efficacy | ORR: 20% (1CR, 4PR, n=25) |
| Clinically Significant Adverse Events | Serious AE: none |
| Conclusion | Tailored-dose chemotherapy with gemcitabine+irinotecan is effective and well tolerated in patients with platinum-refractory/resistant ovarian cancer |
| Reference | Tate S et al. Tailored-dose chemotherapy with gemcitabine and irinotecan in patients with platinum-refractory/resistant ovarian or primary peritoneal cancer: a phase II trial. J Gynecol Oncol (2021) 32(1):e8 |