Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
- Conditions
- Patients with platinum-refractory and resistant ovarian cancer
- Registration Number
- JPRN-UMIN000005525
- Lead Sponsor
- Fukuoka University, School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 6
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The maximum tolerated dose of combination chemotherapy consisting of pegylated liposomal doxorubicin in combination with irinotecan
- Secondary Outcome Measures
Name Time Method