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Carboplatin

Patients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the planned surgical cytoreductive procedure.

Doses as appropriate for assigned dose level in 500 cubic centimeters (cc)

carboplatin

Krishnansu Tewari, MD

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.

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

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.

MTD of HIPEC carboplatin, defined as the dose level with \< 2 patients of 6 experiencing dose-limiting toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Identified using the continual reassessment method.

For 1-year OS rate, death events will be recorded. One-year OS rate will be defined by the number of participants alive 1 year from the time of study entry.

Participants who receive any amount of study drug will be evaluable for toxicity.

Median, range, and interquartile range will be calculated and reported for the amount of carboplatin absorbed from the perfusate, the rate of drug absorption from the peritoneal cavity into the systemic circulation, the 0-to-60 minute area under the curve (AUCs) for peritoneal and plasma platinum concentration curves, the total body clearance, the 0-to-24 hour AUC for filterable platinum in the plasma, and regional advantage. Estimates of population averages will be calculated and reported using 95% confidence intervals.

Measured at in situ tumor sites and at esophageal and bladder tissue (controls). Median, range and interquartile range will be calculated and reported for mean and peak temperature. Average within-patient paired differences of mean temperature will be summarized descriptively. Estimates of the population average difference in mean temperature between tumor and control tissue will be calculated and reported with 95% confidence intervals. Frechet or type-II extreme value distributions will be used to model the peak temperature as measured in tumor sites.

Platinum levels will be measured by inductively coupled plasma mass spectrometry (ICP-MS). Median, range and interquartile range will be calculated and reported for platinum levels per tumor wet weight and per tumor volume. Estimates of population average platinum level will be calculated and reported with 95% confidence intervals as based on measured values or transformed values and the normal approximation.

A linear model will be calculated and reported for the regression of log-transformed total depth of destruction on per-patient mean temperature as measured during perfusion at in-situ tumor sites.

Spots Global Cancer Trial Database for intraperitoneal (ip) chemotherapy