Randomized Phase III Trail of Liposomal Doxorubicin(PLD)50mg/m2 versus Liposomal Doxorubicin(PLD)40mg/m2 in Patients with Platinum-Refractory and -Resistant Mullerian Carcinoma (Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma).
- Conditions
- Patients with platinum-refractory and -resistant Mullerian Carcinoma (epithelial ovarian, fallopian tube, primary peritoneal carcinoma)
- Registration Number
- JPRN-UMIN000003130
- Lead Sponsor
- Japanese Gynecologic Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 470
Not provided
1) Patients who have a history of hypersensitivity to Doxorubicin 2) Patients with active infection 3) Patients with severe complications (Heart disease, uncontrolled diabetes, malignant hypertension, or bleeding tendency) 4) Patients who have any other cancer within the past 5 years 5) Patients have myocardial infarction within 90 days or angina attack. 6) Patients who have treated prior chemotherapy with Anthracycline of a total dose of more than 250 mg/m2 doxorubicin 7) Patients have received prior PLD chemotherapy. 8) Patients have symptomatic brain metastasis with symptom. 9) Patients are pregnant or breast feeding. 10)Patients who are inappropriate to enter this study with any safety reasons,judged by the treating physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Adverse event Response Rate Overall Suvival Tolerability