A Phase II Trial of Liposomal Doxorubicin (PLD) + Carboplatin (CBDCA) as Treatment in Relapsed, Plutinum-sensitive Ovarian Cancer
- Conditions
- Ovarian cancer
- Registration Number
- JPRN-UMIN000003944
- Lead Sponsor
- Osaka University Graduate School of Medicine Department of Obstetrics and Gynecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 85
Not provided
1)Pregnant women, nursing mothers, and those who may be or are willing to be pregnant. 2)Patients with active double cancer (synchronic double cancer and asynchronous double cancer with no more than 5-year disease-free period. However, basal cell carcinoma in the skin, squamous cell carcinoma, and carcinoma in situ judged to be cured by local treatment, or intra-mucosal cancer-equivalent lesion are not to be included in active double cancer). 3)Patients with a severe psychiatric disorder that is considered to interfere with the conduct of this study. 4)Patients with concomitant disease that may affect the conduct of the study and the evaluation of PLD (severe one, or active and systemic infection, etc.). 5)Patients who had myocardial infarction and angina attack within 90 days (if the previous day of the enrollment is the initial date of reckoning, up to 90 days before). 6)Uncontrolled or severe cardiovascular disease including myocardial infarction. 7)Patients who have received bone marrow transplantation or have a therapeutic history of massive chemotherapy + hematopoietic stem cell transplantation. 8)Patients receiving, as prior therapy, anthracycline treatment exceeding 250 mg/m2 as a total doxorubicin equivalent dose. 9)Patients with a poorly controlled restrictive or obstructive pulmonary disease. 10)Patients with symptomatic brain metastasis. 11)Patients who are already receiving treatment with PLD. 12)Patients with a history of severe hypersensitivity. 13)Patients with a past history of hypersensitivity to doxorubicin products and any ingredients of PLD (MPEG-DSPE, soybean hydrogenised phospholipids, cholesterol, ammonium sulfate, histidine, sucrose, hydrochloric acid, sodium hydrochloride). 14)Other patients judged ineligible as subjects for the clinical study by the investigator (or subinvestigator).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best overall response (Response rate)
- Secondary Outcome Measures
Name Time Method 1. The incidence and the degree of adverse events and adverse drug reactions, etc. 2. The median duration of response and the range, etc. in response cases (CR or PR) 3. The median time to response and the range, etc. in response cases (CR or PR)4. The median time to death and the range, etc. in response cases (CR or PR)