Phase I study of pegylated liposomal doxorubicin and cisplatin combination chemotherapy in patients with recurrent and refractory epithelial ovarian cancer.
- Conditions
- epithelial ovarian cancer, primary fallopian tube cancer, primary peritoneal cancer
- Registration Number
- JPRN-UMIN000005798
- Lead Sponsor
- Cancer Institute Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 18
Not provided
1)No evidence of interstitial pneumonitis or pulmonary fibrosis on chest X-ray or CT. 2)Patients with a history of severe hypersensitivity reactions to any drugs. 3)Patients with severe heart disease. 4)Patients with active autoimmune disease. 5)Patients with prior diagnosis of malignancy. Exceptios are: - carcinoma in situ - other malignancies curatively treated and >5 years without evidence of recurrence. 6)Patients with an active or uncontrolled infection.(without chronic viral hepatitis.) 7)Patients with other severe deisease(e.g.,renal failure, liver failure, gastrointestinal ulcer) 8)Patienst with massive ascites or/and pleural effusion. 9)Patients with history of hypersensitivity reactions to cisplatin or other platinum. 10) No prior cumulative anthracycline dose in excess of 250mg/m^2. 11)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 To determine the maximum tolerated dose(MTD) and the recommended dose(RD)
- Secondary Outcome Measures
Name Time Method The incidence of adverse effects The efficacy of chemotherapy (Disease control rate over 4 months)