Phase II study of oral etoposide and intravenous irinotecan for patients with platinum-resistant and taxane-pretreated ovarian cancer: Japan Clinical Oncology Group Study 0503.
A single-arm Phase II study evaluating combination chemotherapy utilizing oral etoposide and irinotecan for platinum-resistant and taxane-pretreated ovarian cancer has started. The aim of this study is to evaluate the efficacy and safety of this regimen as a test arm regimen in a subsequent Phase III trial. Patients with platinum-resistant and taxane-pretreated ovarian cancer are given etoposide at 50 mg/m(2) p.o. from days 1 to 21 and irinotecan 70 mg/m(2) i.v. at days 1 and 15, repeated every 28 days, up to six cycles. A total of 60 patients will be enrolled at 36 institutions. The primary endpoint is response rate. The secondary endpoints include adverse events and progression-free and overall survival.
Hyogo Cancer Center, Kitaoji-cho, Akashi, Hyogo, Japan. kojmatsu@hp.pref.hyogo.jp
Koji
K
Matsumoto
Noriyuki
N
Katsumata
Isamu
I
Saito
Taro
T
Shibata
Ikuo
I
Konishi
Haruhiko
H
Fukuda
Toshiharu
T
Kamura
D000284:Administration, Oral; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001952:Bridged-Ring Compounds / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D019008:Drug Resistance, Neoplasm; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D012107:Research Design; D043823:Taxoids / Q000627:therapeutic use
D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; D005047:Etoposide; D000077146:Irinotecan; D002166:Camptothecin