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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Assess the MTD of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma following surgery and normothermic intraperitoneal and intravenous cisplatin and paclitaxel.
Time frame: 6 months-5 years
To assess the quality of life of patients treated with intraperitoneal hyperthermic chemotherapy in this setting
Time frame: 6 months-5 years
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