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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clemens Tempfer, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01809379
First received: March 8, 2013
Last updated: October 12, 2014
Last verified: October 2014
  Purpose

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


Enrollment: 69
Study Start Date: February 2013
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01809379

Locations
Germany
Ruhr University Bochum
Bochum, NRW, Germany, 44623
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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
ClinicalTrials.gov Identifier: NCT01809379     History of Changes
Other Study ID Numbers: PIPAC-OV1
Study First Received: March 8, 2013
Last Updated: October 12, 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
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Cisplatin
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014