Fallopian Tube Carcinoma Clinical Trial
Official title:
A Phase I Dose-escalation and Pharmacokinetic Study of Hyperthermic Intraoperative Intraperitoneal Chemotherapy (HIPEC) Carboplatin at the Time of Cytoreductive Surgery for the Initial Treatment in Patients With Advanced Ovarian, Fallopian Tube, and Peritoneal Carcinomas.
This phase I trial studies the side effects and best dose of heated carboplatin given into the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it directly into the area around the tumor during surgery may kill more tumor cells.
Primary Objectives:
To determine the maximum tolerated dose (MTD) of carboplatin given as HIPEC for primary
treatment of women with advanced ovarian, peritoneal, and fallopian tube cancers.
Secondary Objectives:
1. To determine the dose limiting toxicities of HIPEC carboplatin.
2. To describe the pharmacokinetic profile of HIPEC carboplatin.
3. To quantify changes in tissue temperature during HIPEC and compare to conventional
temperature measures (esophageal and bladder).
4. To describe the extent of thermal damage and DNA platinum adduct formation in tissues
resulting from HIPEC carboplatin.
OUTLINE: This is a dose escalation study.
Patients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the
planned surgical cytoreductive procedure.
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