Dose finding study of the combination chemotherapy consisting of irinotecan hydrochloride and pegylated liposomal doxorubicin combination therapy in patients with recurrent ovarian cancer (Phase I trial) - Phase I trial of CPT-11/PLD for recurrent ovarian cancer

School of Medicine, Keio University Obstetrics and Gynecology0 个研究点目标入组 18 人开始时间: 2010年11月22日最近更新: 2023年10月17日

适应症

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•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.

发起方

School of Medicine, Keio University Obstetrics and Gynecology