Phase I Study of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion With Cisplatin in Patients With Recurrent Ovarian Cancer
This is a phase I dose escalating study designed to identify tolerable, clinically active
doses of cisplatin delivered as intraoperative intraperitoneal hyperthermic chemoperfusion
(HIPEC) in patients with platinum-sensitive recurrent ovarian cancer. After surgical
cytoreduction, a single dose of cisplatin will be administered in 3 liters normal saline via
intraperitoneal HIPEC with closed-abdomen technique for 90 minutes in the hyperthermic phase
(41-43 degrees C). After completion of perfusion, the perfusate will be drained, the abdomen
opened and the abdomen and pelvis irrigated with 2-3 liters normal saline to wash away any
residual chemotherapeutic agent. Fascia and skin will then be closed in a standard fashion.
Cisplatin infusion will be discontinued for unacceptable toxicity. The primary objective
is to determine the maximum tolerated dose (MTD) of cisplatin administered as HIPEC.
Secondary objectives are to determine pharmacokinetics and pharmacodynamics as well as the
effect of cisplatin as HIPEC on the ability to subsequently administer 6 cycles of standard
platinum-based systemic chemotherapy.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety and maximum tolerated dose (MTD) of cisplatin (60 mg/m², 80mg/m² and 100 mg/m²) administered as intraperitoneal hyperthermic chemoperfusion defined by the dose-limiting toxicity (DLT).
within the first 21days after surgery
Oliver Zivanovic, MD
University Hospital, Bonn
Germany: Federal Institute for Drugs and Medical Devices
EudraCT No.: 2010-024652-28