MedPath

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

Phase 1
Conditions
Gynecological Mullerian tumors, such as ovarian, tubal, and peritoneal cancers.
Registration Number
JPRN-C000000115
Lead Sponsor
atinonal Hospital Organization Kobe Medical Center
Brief Summary

By now 12 patients were recruited, and all patients were completed. As for pharmacokinetics and adverse events the results were reported at 2004 ASCO procedings. At ECCO 12 meeting the presentation was made according to the results except for survival. The survivals and outcome would be reported soon.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
12
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
definition of recommended dose and assessment of feasibility of the treatment
Secondary Outcome Measures
NameTimeMethod
response (using CA125 according to Rustin's criteria, reduction of ascitic fluid), time to progression
© Copyright 2025. All Rights Reserved by MedPath