A phase I/II study of weekly intraperitoneal paclitaxel +monthly intravenous carboplatin for mullerian carcinoma (ovarian, tubal, and peritoneal carcinoma)

UMIN ID: C000000115

Registered date:09/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gynecological Mullerian tumors, such as ovarian, tubal, and peritoneal cancers.
• Date of first enrollment: 2001/03/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): An estimation of MTD/RD of intraperitoneal administration with paclitaxel weekly in Carboplatin/paclitaxel regimens for optimal debulked ovarian cancer.

Outcome(s)

• Primary Outcome: definition of recommended dose and assessment of feasibility of the treatment
• Secondary Outcome: response (using CA125 according to Rustin's criteria, reduction of ascitic fluid), time to progression

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Natinonal Hospital Organization Kobe Medical Center
• Secondary Sponsor: Osaka Medical College, Kobe University, Iwate Medical University, Tottori University
• Source(s) of Monetary Support: Grant of Ntional Cancer Center Hospital:Grant for cancer study 2002 from Ministry of Health, Labour and Welfare