Patients with platinum-refractory and resistant ovarian cancer
Conditions
Interventions
PLD (25-30mg/m2 ,day1) CPT-11 (50-60mg/m2 , day 1,8)
Sponsors
Fukuoka 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 1st-line or 2nd-line chemotherapy of platinum is required. Platinum-based regimen and is defined as progressive disease within 12 months of completing the prior therapy. 4) Patients took 3 coourse or more Platinum-based chemotherapy as 1st- or 2nd-line chemotherapy. 5) ECOG Performance Status: 0-1. 6) Patients who have genetic polymorphism of UGT1A1 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 Serum 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 with bowel paralysis or obstruction. 8) Patients with diarrhea or watery stool. 9) Patients with apparent interstitial pneumonitis or pulmonary fibrosis 10) Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation. 11) Patients who have received prior chemotherapy consisting of pegylated liposomal doxorubicin. 12) Patients who have participated in other clinical trials. 13) Patients with history of hypersensitivity reactions to doxorubicin or irinotecan or the components of pegylated liposomal doxorubicin. 14) Patients who are pregnant, lactating, and have pregnant possibility or intention. 15) Patients who are decided to be ineligible for this trial by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum tolerated dose of combination chemotherapy consisting of pegylated liposomal doxorubicin in combination with irinotecan | — |
Countries
Japan
Outcome results
None listed