Open-label Study to Verify Effectiveness, Safety of Pegylated Liposomal Doxorubicin 50 mg/m2 Administered Every 4 Weeks to Patients With Mullerian Carcinoma (Epithelial Ovarian Carcinoma, Primary Carcinoma of Fallopian Tube, Peritoneal Carcinoma) Who Have Undergone Prior Platinum-based Chemotherapy.
Pegylated liposomal Doxorubicin hydrochloride is intended to change the pharmacokinetics of
conventional doxorubicin in the blood and to improve the safety and effectiveness of the
drug. Pegylated liposomal doxorubicin hydrochloride has been approved in many countries
including US and EU, becoming a standard drug for 2nd-line therapy in ovarian cancer and
AIDS-related Kaposi's Sarcoma. This clinical study was planned to assess effectiveness and
safety for Japanese patients with Müllerian carcinoma (including epithelial ovarian
carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma), who had a prior
history of receiving platinum-based chemotherapy such as Cisplatin (which is considered to
be the standard chemotherapy for ovarian carcinoma). In this study, at least two cycles of
pegylated liposomal doxorubicin hydrochloride 50 mg/m2 will be intravenously administered to
80 patients every 4 weeks. These patients include twenty 2nd-line "platinum-sensitive" and
sixty "platinum-resistant" 2nd-line or 3rd-line patients. Pegylated liposomal doxorubicin
hydrochloride 50 mg/m2 will be given by intravenous drip infusion on day 1. After this, a
27-day drug-free period will be followed as one cycle. At least two cycles will be given as
long as the patient does not meet the discontinuation criteria.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate as antitumor effect (tumor shrinkage)
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center