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Phase I Study of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion With Cisplatin in Patients With Recurrent Ovarian Cancer

Phase 1
18 Years
70 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

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.

Inclusion Criteria:

- only female participants are being studied

- signed informed consent

- patients with histologically proven or suspicious recurrent epithelial ovarian cancer
(based on Response Evaluation Criteria in Solid Tumors (RECIST)- or CA-125 criteria)

- Progression-free interval after completion of adjuvant platinum-based chemotherapy of
6 months or more.

- Subjects with the following histologic epithelial cell types are eligible: serous
adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell
adenocarcinoma, adenocarcinoma N.O.S.

- Patients are eligible if the disease is deemed operable to equal or less than 1 cm at
the completion of surgery.

Exclusion Criteria:

- mucinous Ovarian cancer

- non-invasive Borderline tumor

- subjects who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded. Prior radiation for localized cancer of the breast, head and
neck, or skin are permitted, provided that it was completed more than 3 years prior
to enrollment, and the subject remains free of recurrent or metastatic disease

- subjects with active infection that requires parenteral antibiotics

- patients with any underlying cardiac, pulmonary, metabolic, renal, hepatic or
gastrointestinal conditions, chronic or latent infectious diseases, immune
deficiency, or history, which in the opinion of the investigator, places the patient
at an unacceptable risk for participation in the study

- patients with known platinum allergy

- evidence of extensive intraperitoneal adhesions at the time of surgery, as determined
by the operating surgeon

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity

Outcome Description:

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).

Outcome Time Frame:

within the first 21days after surgery

Safety Issue:


Principal Investigator

Oliver Zivanovic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bonn


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EudraCT No.: 2010-024652-28



Start Date:

June 2011

Completion Date:

July 2013

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • recurrence
  • platinum-sensitive recurrent ovarian cancer
  • intraperitoneal chemotherapy
  • hyperthermic intraperitoneal chemoperfusion
  • cisplatin
  • Platinum-sensitive recurrent ovarian cancer
  • Fever
  • Ovarian Neoplasms