ovarian cancer
Conditions
Interventions
case series:Pegylated liposomal doxorubicin 40 mg/m2, i.v., d1
repeat every 28 days, 4~6 cycles.
Sponsors
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75years old female; 2. Subjects had histopathologically confirmed with epithelial ovarian cancer / fallopian tube/peritoneal cancer; 3. Recurrence within 12 months after first-line chemotherapy with platinum-based drugs; (1) Satisfactory degree of resection was achieved in the primary cytoreductive surgery (resection or basic resection, residual tumors < 1cm); (2) Patients with early ovarian cancer have previously received no more than one platinum-containing regimen for 3 to 6 cycles. Patients with advanced ovarian cancer have previously received no more than one platinum-containing regimen for 6-8 cycles, followed by CR, and relapse within 12 months after chemotherapy; 4. Uncontrolled/refractory ovarian cancer after first-line chemotherapy with platinum-based drug regimen: (1) Satisfactory primary cytoreductive surgery, post-operative first-line chemotherapy, clinical failure to achieve CR, CA125 has been abnormal or tumor progression during chemotherapy; (2) Unsatisfactory primary cytoreductive surgery, postoperative CR after first-line chemotherapy, recurrence within 12 months after chemotherapy;?Unsatisfied with primary cytoreductive surgery, continuous progression after first-line chemotherapy; 5. Did not receive other chemotherapy drugs after relapse or first-line chemotherapy; 6. Imaging assessment is based on the solid tumor efficacy evaluation standard (RECIST) version 1.1, lesions can be measured, or patients CA125 assessed according to GCIG criteria; 7. ECOG score = 2; 8. Expected survival time = 3 months; 9. LVEF = 50%; 10. Laboratory tests: Bone Marrow Function: ANC=1.5×10^9/L PLT=80×10^9/L; Hb =80g/L; Liver and renal function: Serum creatinine = normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=ULN 2.5times, or <ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level= ULN 2.5 times; 11. Signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Other malignant tumors have been found in the past 5 years; 2) Patients who had not been treated with surgery in first-line treatment and treated with chemotherapy alone; 3) The New York Heart Association (NYHA) graded class II heart disease patients (including grade II) previous or current; 4) Patients had a total cumulative dose of doxorubicin =300mg/m2, or a total cumulative dose of epirubicin = 550 mg/m2, or with previous anthracycline-induced heart disease; 5) Patients who had previously received pelvic or abdominal radiotherapy; 6) Uncontrolled systemic infection requiring anti-infective treatment; 7) Allergies to chemotherapeutic drugs or their excipients or intolerant patients; 8) Patients with central nervous system disease or central nervous system metastasis; 9) Receive other chemotherapy drugs within 28 days prior to the first chemotherapy administration; 10) Researchers think it is not suitable for enrolling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response rate;disease control rate;health-related quality of life assessment; | — |
Countries
China
Contacts
Public ContactKeng Shen
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Outcome results
None listed