Spots Global Cancer Trial Database for Heated Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Peritoneal Cancer

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Trial Identification

Brief Title: Heated Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Peritoneal Cancer

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.

Study ID: NCT02199171

Conditions

FIGO Stage IIC-IV Ovarian Carcinoma

Fallopian Tube Carcinoma

Peritoneal Carcinoma

Interventions

carboplatin

Study Description

Brief Summary: 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.

Detailed Description: 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.