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Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer

Primary Purpose

Recurrent Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
chemotherapy with doxorubicin and cisplatin
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Ovarian Cancer focused on measuring ovarian cancer, recurrent, chemotherapy, intraperitoneal

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • at least 2 lines of previous chemotherapy
  • recurrent ovarian cancer
  • patient is mobile
  • informed consent

Exclusion Criteria:

  • ileus
  • necessity of parenteral nutrition

Sites / Locations

  • Ruhr University Bochum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intraperitoneal chemotherapy

Arm Description

Intraperitoneal chemotherapy with cisplatin at a dose of 7.5 mg/m2 body surface in a 150 ml NaCl 0.9% and doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution with a flow of 30 ml/min and a max upstream pressure of 200 psi.

Outcomes

Primary Outcome Measures

Clinical Benefit Rate
The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.

Secondary Outcome Measures

safety
left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy complications postoperative until hospital discharge, re-admission to hospital, death

Full Information

First Posted
March 8, 2013
Last Updated
July 7, 2022
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT01809379
Brief Title
Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer
Official Title
Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer
Detailed Description
This study aims to investigate the therapeutic efficacy of PIPAC using doxorubicin and cisplatin in women with recurrent ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Ovarian Cancer
Keywords
ovarian cancer, recurrent, chemotherapy, intraperitoneal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intraperitoneal chemotherapy
Arm Type
Experimental
Arm Description
Intraperitoneal chemotherapy with cisplatin at a dose of 7.5 mg/m2 body surface in a 150 ml NaCl 0.9% and doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution with a flow of 30 ml/min and a max upstream pressure of 200 psi.
Intervention Type
Drug
Intervention Name(s)
chemotherapy with doxorubicin and cisplatin
Other Intervention Name(s)
CISPLATIN Teva, Adrimedac
Intervention Description
intraperitoneal chemotherapy applied as an aerosol and under pressure
Primary Outcome Measure Information:
Title
Clinical Benefit Rate
Description
The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
safety
Description
left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy complications postoperative until hospital discharge, re-admission to hospital, death
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
tumor apoptosis assessment, videolaparoscopy assessment of response, CA 125 assessment of response
Description
various measures of response to therapy on the clinical, biochemical, and histological level
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least 2 lines of previous chemotherapy recurrent ovarian cancer patient is mobile informed consent Exclusion Criteria: ileus necessity of parenteral nutrition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens Tempfer, MD
Organizational Affiliation
Runr University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruhr University Bochum
City
Bochum
State/Province
NRW
ZIP/Postal Code
44623
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25701703
Citation
Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18.
Results Reference
result

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Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer

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