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

Primary Purpose

Ovarian Cancer

Status

Unknown status

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, recurrence, platinum-sensitive recurrent ovarian cancer, HIPEC, intraperitoneal chemotherapy, hyperthermic intraperitoneal chemoperfusion, cisplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cisplatin as HIPEC

Arm Description

Phase I dose escalating study of cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion

Outcomes

Primary Outcome Measures

Dose-limiting toxicity

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).

Secondary Outcome Measures

Pharmacokinetics

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.

Number of cycles of standard intravenous platinum-based systemic chemotherapy

Measure the effect of cisplatin as HIPEC on the ability to subsequently administer 6 cycles of standard intravenous platinum-based systemic chemotherapy.

Full Information

NCT ID

NCT01387399

First Posted

June 24, 2011

Last Updated

February 14, 2013

Sponsor

University Hospital, Bonn

1. Study Identification

Unique Protocol Identification Number

NCT01387399

Brief Title

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

Acronym

HIPEC ROC I

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Bonn

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

ovarian cancer, recurrence, platinum-sensitive recurrent ovarian cancer, HIPEC, intraperitoneal chemotherapy, hyperthermic intraperitoneal chemoperfusion, cisplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cisplatin as HIPEC

Arm Type

Experimental

Arm Description

Phase I dose escalating study of cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion

Intervention Type

Procedure

Intervention Name(s)

Cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion

Intervention Description

Classical "3+3" dose escalation study of cisplatin administered as HIPEC (60mg/m², 80mg/m² and 100mg/m²)

Primary Outcome Measure Information:

Title

Dose-limiting toxicity

Description

Time Frame

within the first 21days after surgery

Secondary Outcome Measure Information:

Title

Pharmacokinetics

Description

Time Frame

within 24 hours of HIPEC

Title

Number of cycles of standard intravenous platinum-based systemic chemotherapy

Description

Measure the effect of cisplatin as HIPEC on the ability to subsequently administer 6 cycles of standard intravenous platinum-based systemic chemotherapy.

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Zivanovic, MD

Organizational Affiliation

University Hospital, Bonn

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital

City

Bonn

ZIP/Postal Code

53127

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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