A Phase I Study of Intraperitoneal Hyperthermic Docetaxel
NCT00474669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2018-01-09
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.
Conditions
- Ovarian Carcinoma
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
James Graham Brown Cancer Center
collaborator OTHER -
University of Louisville
lead OTHER
Principal Investigators
-
C. William Helm, MD · James Graham Brown Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2009-12-31
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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