Epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer in late relapse (>
Conditions
Interventions
Combination chemotherapy consisting of pegylated liposomal doxorubicin (30 mg/m2 iv, day1) and carboplatin (AUC=5 iv, day1) will be administered every 4 weeks. Patients is planned to receive at least
Sponsors
Keio University, School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with a histologic diagnosis of epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer. 2. Age: 20 years old or older, and under 75 years old. 3. Patients with recurrent disease in late relapse (>6 months) after 1st-line chemotherapy. 4. Patients who have measurable disease by RECIST. 5. Patients who received 1st-line chemotherapy consisting of taxane and carboplatin. 6. ECOG Performance Status: 0-1. 7. Reasonable organ function. WBC: 3,000-12,000/mm3 ANC: >1,500/mm3 Hb: >10.0g/dL Platelet: >75,000/mm3 AST, ALT: less than or equal to 2.5x institutional ULN ALP: less than or equal to 2.5x institutional ULN Bilirubin: less than or equal to institutional ULN Seroum creatinine: less than or equal to 1.5x institutional ULN LVEF: 50% or more ECG: within normal limits 8. Patients must have signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe complications or active infection. 2. Patients with prior diagnosis of malignancy are not eligible. Exceptions are: -non-melanoma skin cancer, and carcinoma in situ. -other malignancies curatively treated and > 5 years without evidence of recurrence. 3. Patients with massive pleural effusion and/or ascites. 4. Patients with massive pericardial fluid. 5. Patients with unstable angina or those who have had a myocardial infarction within the past 90 days. 6. Patients with brain metastasis who have symptoms or require administration of steroid or antihydropic. 7. Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation. 8. Patients who have received prior chemotherapy consisting of pegylated liposomal doxorubicin. 9. Patients who have participated in other clinical trials. 10. Patients who have received prior chemotherapy consisting of doxorubicin. 11. Patients with history of hypersensitivity reactions to the components of pegylated liposomal doxorubicin. 12. Patients who are pregnant, lactating, and have pregnant possibility or intention. 13. Patients who are decided to be ineligible for this trial by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best overall response (Response rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events, overall survival, and progression-free survival. | — |
Countries
Japan
Outcome results
None listed