Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study
Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the
cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to
systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be
a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by
the body surface is still highly variable and thus dosing on the body surface is increasingly
considered controversial for systemic administration.
For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes
even less sense, since the aim is the highest possible drug concentration in the peritoneum
without undue local and systemic toxicity. Furthermore, most studies using intraoperative
chemotherapy vary the volume of the perfusate according to the size of the patient. Since the
amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] =
dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can
vary considerably between patients. On the other hand pharmacokinetic analyses have shown
that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy
even if the amount of the drug remains the same.
In this study the safety of a new dosing regime will be evaluated. The concentration of
cisplatin in the perfusate will be held constant independent of body weight or size to
achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of
the treatment. All patients should be able to receive full dose systemic carboplatin
chemotherapy after completion the trial treatment.