Epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer recurred during the present chemotherapy or within 6 months after the prior chemotherapy.
Conditions
Interventions
Combination chemotherapy consisting of irinotecan hydrochloride (the following dose level, on day1, 8 and 15) and pegylated liposomal doxorubicin (40 mg/m^2, on day3) will be administered intravenousl
Sponsors
School of Medicine, Keio University Obstetrics and Gynecology
St. Marianna 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. Patients who received chemotherapy consisting of platinum. 3. Patients with platinum resistant/refractory recurrent disease. 4. Patients who received chemotherapy within two regimens. 5. ECOG Performance Status: 0-1. 6. Reasonable organ function. WBC: 3,000-12,000/mm3 ANC: >1,500/mm3 Hb: >10.0g/dL Platelet: >100,000/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 1.5x institutional ULN Serum creatinine: less than or equal to 1.5x institutional ULN No suffering from diarrhea LVEF: 50% or more ECG: within normal limits 7. Patients who do not be administered CSF or transfused within two weeks at registration. 8. Patients who have the following periods. 4 weeks or more after the prior surgery 4 weeks or more after the prior radiotherapy 2 weeks or more after the prior chemotherapy, such as hormonal drug, oral antimetabolite, immunetherapy. 6 weeks or more after the prior chemotherapy, such as nitrosourea and mitomycin C. 4 weeks or more after other prior chemotherapy. 9. Patients expected of three months or more survival. 10. Age: 20 years old or older, and under 80 years old. 11. 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 who have received prior chemotherapy consisting of irinotecan or anthracyclins. 7. Patients with brain metastasis who have symptoms or require administration of steroid or antihydropic. 8. Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation. 9. Patients who have participated in other clinical trials. 10. Patients with history of hypersensitivity reactions to irinotecan or the components of pegylated liposomal doxorubicin. 11. Patients who are pregnant, lactating, and have pregnant possibility or intention. 12. Patients with diarrhea or watery stool. 13. Patients with bowel paralysis or obstruction. 14. Patients with apparent interstitial pneumonitis or pulmonary fibrosis on chest X-ray. 15. Patients who are receiving Atazanavir. 16. Patients who have genetic polymorphism of homo UGT1A1*6 or *28, or hetero UGT1A1*6 and *28 17. 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 irinotecan hydrochloride and pegylated liposomal doxorubicin. | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events and Response Rate. | — |
Countries
Japan
Contacts
Public ContactHiroshi Tsuda
School of Medicine, Keio University Obstetrics and Gynecology
Outcome results
None listed