Patients with platinum-refractory and -resistant Mullerian Carcinoma (epithelial ovarian, fallopian tube, primary peritoneal carcinoma)
Conditions
Interventions
Liposomal Doxorubicin(PLD)50mg/m2
Liposomal Doxorubicin(PLD)40mg/m2
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Mullerian Carcinoma(epithelial ovarian, fallopian tube, or primary peritoneal carcinoma) 2)Prior platinum-based chemotherapy is required. Platinum-resistant disease is based on the most recent exposure to a platinum-based regimen and is defined as progressive disease within 6 months of completing the prior therapy. Criteria eligibility also included the presence of measurable disease. 3)No more than two prior regimens are allowed. 4)No chemotherapy within 4 weeks prior to the registration 5)Age:20 years old -79 years old 6)Performance status:ECOG 0-2 7)Adequate bone marrow, renal, and hepatic function 8)Patients are expected to live more than 3 months. 9)Patients who have signed an approved informed consent.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event Response Rate Overall Suvival Tolerability | — |
Countries
Japan
Contacts
Public ContactTsutomu Tabata ,M.D.,
JGOG3018 Coordinating Office Mie University Hospital Department of Obsterics and Gynecology
Outcome results
None listed