Clinical trial NCT01387399: Safety and Pharmacokinetics of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) With Cisplatin to Treat Platinum-sensitive Recurrent Ovarian Cancer
Official title: Phase I Study of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion With Cisplatin in Patients With Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ovarian Cancer
Keywords: ovarian cancer
recurrence
platinum-sensitive recurrent ovarian cancer
HIPEC
intraperitoneal chemotherapy
hyperthermic intraperitoneal chemoperfusion
cisplatin
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this phase I study is to determine the safety, feasibility, maximum tolerated dose (MTD), pharmacokinetics and pharmacodynamics of Cisplatin administered as Intraoperative Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients with Platinum-Sensitive Recurrent Ovarian Cancer.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: within the first 21days after surgery
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: within 24 hours of HIPEC
measure: Number of cycles of standard intravenous platinum-based systemic chemotherapy
timeFrame: 3 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital
Study officials:
affiliation: University Hospital, Bonn
name: Oliver Zivanovic, MD
role: PRINCIPAL_INVESTIGATOR
References: