epithelial ovarian cancer, primary fallopian tube cancer, primary peritoneal cancer
Conditions
Interventions
Combination chemotherapy with pegylated liposomal doxorubicin and cisplatin 1)Dose level of CDDP Level-1 30mg/m^2 Level 1 40mg/m^2 Level 2 50mg/m^2 Level 3 60mg/m^2 Level 4 70mg/m^2 In each dos
Sponsors
Cancer Institute Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with a histological or clinical diagnosis of epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer. 2) FIGO stage: I-IV Recurrence or refractory after previous systemic chemotherapy. No prior chemotherapy with PLD 3) Age: 20-75 years old 4) ECOG Performance Status: 0-1 5) Patients with/without measureable disease. 6) Adequate organ function ANC: more than or equal to 1500/mm3 Plt: more than or equal to 100,000/mm3 T.Bil: less than or equal to 1.5mg/dl AST(GOT): less than or equal to 100IU/L ALT(GPT): less than or equal to 100IU/L S-Cr: less than or equal 1.2mg/dl ECG: within normal limits LVEF: 50% or more 7) Patients must have signed informed consent of this trial.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose(MTD) and the recommended dose(RD) | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse effects The efficacy of chemotherapy (Disease control rate over 4 months) | — |
Countries
Japan
Contacts
Public ContactHaruko Iwase
Cancer Institute Hospital Department of Gynecology
Outcome results
None listed