Safety and Pharmacokinetics of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) With Cisplatin to Treat Platinum-sensitive Recurrent Ovarian Cancer (HIPEC ROC I)

February 14, 2013 updated by: Oliver Zivanovic, University Hospital, Bonn

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cisplatin as HIPEC
Phase I dose escalating study of cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion
Procedure: Cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion
Classical "3+3" dose escalation study of cisplatin administered as HIPEC (60mg/m², 80mg/m² and 100mg/m²)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity
Time Frame: within the first 21days after surgery
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: within 24 hours of HIPEC
Blood and peritoneal concentrations of cisplatin will be measured at various time points within the first 24 hours after HIPEC. The elimination half-life and the area under the plasma concentration time curve of cisplatin will be measured. Peritoneal and systemic clearance and distribution of cisplatin will be modeled in a compartmental model.
within 24 hours of HIPEC
Number of cycles of standard intravenous platinum-based systemic chemotherapy
Time Frame: 3 months
Measure the effect of cisplatin as HIPEC on the ability to subsequently administer 6 cycles of standard intravenous platinum-based systemic chemotherapy.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Oliver Zivanovic, MD, University Hospital, Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

June 24, 2011

First Submitted That Met QC Criteria

July 1, 2011

First Posted (Estimate)

July 4, 2011

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT No.: 2010-024652-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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