Gynecological Mullerian tumors, such as ovarian, tubal, and peritoneal cancers.
Conditions
Interventions
An estimation of MTD/RD of intraperitoneal administration with paclitaxel weekly in Carboplatin/paclitaxel regimens for optimal debulked ovarian cancer.
Sponsors
Natinonal Hospital Organization Kobe Medical Center
Osaka Medical College, Kobe University, Iwate Medical University, Tottori University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Histological diagnosed gynecological Mullerian cancers,such as ovarian, tubal, and peritoneal cancer stage over IC(IC-IV) or recurrent disease with pelvic disease (retention of ascitic fluid, para-aortic nodes recurrence) with optimal debulked surgery. (2)Adequate organ function with; ANC>1,500/mm3, platelets>100,000/mm3,Hb>9.0g/dl, S-GOT,GPT 40ml/min. EKG:normal, without heart disease and severe arhythmia (3)ECOG Performance Status 0-2 (4)Patients expected to survive at least 6 months (5)Patients who will be gotten fully informed consent for the clinical study
Exclusion criteria
Exclusion criteria: (1)Whom not to be suitable for eligibility criateria (2)Known severe hypersensitivityor having past illness of hypersensitivity to any drug (3)pregnant,milk-feeding woman or who is expected to be pregnant (4)Who have too much pleural effusion or pericardial effsion. (5)Known hypersensitivity to these drugs(paclitaxel, and/or carboplatin) or to agent containing polyoxiethilene cremophol such as cyclosporine injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| definition of recommended dose and assessment of feasibility of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| response (using CA125 according to Rustin's criteria, reduction of ascitic fluid), time to progression | — |
Countries
Japan
Contacts
Public ContactSatoshi Takeuchi
Natinonal Hospital Organization Kobe Medical Center Gynecologic Oncology
Outcome results
None listed