%0 Journal Article %A S. Nishimura %A H. Tsuda %A Y. Hashiguchi %A K. Kokawa %A R. Nishimura %A O. Ishiko %A S. Kamiura %A K. Hasegawa %A N. Umesaki %T Phase II study of irinotecan plus doxorubicin for early recurrent or platinum-refractory ovarian cancer: interim analysis %D 2007 %R 10.1111/j.1525-1438.2006.00728.x %J International Journal of Gynecologic Cancer %P 159-163 %V 17 %N 1 %X The aim of this study was to evaluate the efficacy and toxicity of irinotecan and doxorubicin in the treatment of patients with early recurrent or platinum-refractory ovarian cancer. Nineteen woman from five different institutions were treated. Two patients had platinum-refractory cancer, 11 had platinum-resistant disease, and 6 had platinum-sensitive tumors. An intravenous infusion of Irinotecan (50mg/m2) was given on days 1, 8, and 15, while doxorubicin (40mg/m2) was administered as an intravenous bolus on day 3. This treatment schedule was repeated every 4 weeks. Among the 13 patients defined as having platinum-refractory/platinum-resistant disease, 4 patients achieved a clinical response (30.8%, 95% CI: 9.1–61.4), while only one of 6 patients defined as having platinum-sensitive disease achieved a clinical response (16.7%, 95% CI: 0.4–64.1). Leukopenia and neutropenia were the major dose- limiting toxicities. Grade 3 or 4 leukopenia and neutropenia were noted in 24 (48%) and 33 (66%) of the courses, while febrile neutropenia occurred in 2 courses. Five patients (26%) had grade 2 or worse diarrhea during 7 courses. Our data demonstrated that this regimen might be comparable to standard approved agents in patients with early recurrent or platinum refractory ovarian cancer. %U https://ijgc.bmj.com/content/ijgc/17/1/159.full.pdf