Recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tubal carcinoma, or primary peritoneal carcinoma)
Conditions
Interventions
PLD (25-30mg/m2 ,day1)+TXT (50-60mg/m2 , day 1)
Sponsors
Kansai Clinical Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with a histological or cytological diagnosis of Mullerian carcinoma (epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma) 2) Patients who are 20 years old or older and younger than 75 years old at the enrollment 3) Patients with recurrence within 12 months after the final course of the first line platinum-based chemotherapy (including recurrence according to marker). 1. Definition of recurrence according to marker: definition of progression according to CA125 (GCIG, 2000) A) Patients with elevated CA 125 pretreatment and normalization of CA 125 ;Doubling in CA 125 from the upper limit of institutional normal range on two occasions Date of progression: first date of the doubling in CA 125 from the institutional upper normal limit B) Patients with elevated CA 125 pretreatment, which never normalizes ;Doubling in CA 125 from the nadir on two occasions Date of progression: first date of the doubling in CA 125 from the nadir C) Patients with CA 125 in normal range at the pretreatment are as for A 4) Patients who received first line platinum-based chemotherapy 5) ECOG Performance Status(Appendix 1): 0-2 6) Patients who satisfy following organ functions A) bone marrowfunction WBC;3000-12000/mm3 ANC;>=1500/mm3 Hb;>=9.0g/dL Paltelet;>=100000/mm3 B)Liver function AST,ALT,ALP;2.5 times of institutional upper normal limit or less Bilirubin;<1.2mg/dL C)Renal function Serum creatinine;1.5 times of institutional upper normal limit or less D)Cardiac function LVEF>=50% ECG;within normal limits or no symptoms without the need of treatment 7) Patients who are expected to survive more than 3 months 8) Patients who have signed informed consent by their own will after they have received a sufficient explanation about the content of the study using the prescribed informed consent form and other explanatory documents 9) Patients who have passed 4 weeks or more since prior treatment
Exclusion criteria
Exclusion criteria: 1) Patients with complications (severe complications or active systemic infection) that may affect the study or assessment of the drugs) 2) Patients with diagnosis of active multiple cancers (synchronous multiple cancers and metachronous multiple cancers within 5 years of disease free interval: exceptions are basal cell carcinoma and squamous cell carcinoma, carcinoma in situ that is curatively treated by local treatment, and intramucosal carcinoma like lesion.) 3) Patients with angina or myocardial infarction within the past 90 days (previous day of the enrollment is defined as day 1 and up to 90 days) 4) Patients who have brain metastasis with symptoms or patients with brain metastasis requiring administration of steroid or antihydropic 5) Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation 6) Patients who have received prior chemotherapy consisting of anthracycline (including PLD) or docetaxel 7) Patients with history of hypersensitivity reactions to the components of anthracycline, taxane, or liposomal doxorubicin (MPEG-DSPE, hydrogenated lecithin, cholesterol, ammonium sulfate, histidine, sucrose, hydrochloric acid, sodium hydroxide) 8) Patients who are pregnant, lactating, and have pregnant possibility or intention 9) Patients who are decided to be ineligible for this study by the principal investigator (or subinvestigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To define the RD of PLD in combination with TXT. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the best overall response (response rate) and safety of PLD in combination with TXT. | — |
Countries
Japan
Contacts
Public ContactKensuke Hori
kansai rousai hospital Obstetrics and gynecology
Outcome results
None listed