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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Ruhr University of Bochum
Information provided by (Responsible Party):
Clemens Tempfer, Ruhr University of Bochum Identifier:
First received: March 8, 2013
Last updated: March 27, 2014
Last verified: March 2014

This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

Condition Intervention Phase
Recurrent Ovarian Cancer
Drug: chemotherapy with doxorubicin and cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.

Secondary Outcome Measures:
  • safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy complications postoperative until hospital discharge, re-admission to hospital, death

Other Outcome Measures:
  • tumor apoptosis assessment, videolaparoscopy assessment of response, CA 125 assessment of response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    various measures of response to therapy on the clinical, biochemical, and histological level

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intraperitoneal chemotherapy
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.
Drug: chemotherapy with doxorubicin and cisplatin
intraperitoneal chemotherapy applied as an aerosol and under pressure
Other Name: CISPLATIN Teva, Adrimedac

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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • ileus
  • necessity of parenteral nutrition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01809379

Contact: Clemens Tempfer, MD +49 2323 499 ext 1801

Ruhr University Bochum Recruiting
Bochum, NRW, Germany, 44623
Contact: Clemens Tempfer, MD    +49 2323 499 ext 1801   
Sponsors and Collaborators
Ruhr University of Bochum
Principal Investigator: Clemens Tempfer, MD Runr University Bochum
  More Information

No publications provided

Responsible Party: Clemens Tempfer, Prof. Dr. med. Clemens Tempfer, MBA, Ruhr University of Bochum Identifier: NCT01809379     History of Changes
Other Study ID Numbers: PIPAC-OV1
Study First Received: March 8, 2013
Last Updated: March 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ruhr University of Bochum:
ovarian cancer, recurrent, chemotherapy, intraperitoneal

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Liposomal doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 18, 2014