NCT00474669

A Phase I Study of Intraperitoneal Hyperthermic Docetaxel

A Phase I Study of Intraperitoneal Hyperthermic Docetaxel at the Time of Second Look Surgery Following Front-Line Normothermic Intraperitoneal and Intravenous Cisplatin/Paclitaxel for Patients With Stage II and III Ovarian Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma.

Detailed description

This is a phase I study of intraperitoneal hyperthermic docetaxel given at the time of second look surgery following front-line normothermic intraperitoneal and intravenous cisplatin/paclitaxel for patients with stage II and III ovarian carcinoma. The primary objectives are to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at this time and assess the toxicity and morbidity associated with this treatment. Eligible patients will have had a complete clinical response to front-line therapy.

Conditions

• Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	docetaxel	Docetaxel will be administered in normal-saline delivered at an inflow temperature of 42 degreesC for 90 minutes by the technique described in Appendix D of the protocol

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-05-17
• Last updated: 2018-01-09

Locations

1 site across 1 country: United States