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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01809379
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : October 15, 2014
Information provided by (Responsible Party):
Clemens Tempfer, Ruhr University of Bochum

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

Condition or disease Intervention/treatment Phase
Recurrent Ovarian Cancer Drug: chemotherapy with doxorubicin and cisplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Clinical Benefit Rate [ Time Frame: 6 months ]
    The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.

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

Other Outcome Measures:
  1. tumor apoptosis assessment, videolaparoscopy assessment of response, CA 125 assessment of response [ Time Frame: 6 months ]
    various measures of response to therapy on the clinical, biochemical, and histological level

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01809379

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Ruhr University Bochum
Bochum, NRW, Germany, 44623
Sponsors and Collaborators
Ruhr University of Bochum
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Principal Investigator: Clemens Tempfer, MD Runr University Bochum
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Responsible Party: Clemens Tempfer, Prof. Dr. med. Clemens Tempfer, MBA, Ruhr University of Bochum Identifier: NCT01809379    
Other Study ID Numbers: PIPAC-OV1
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Keywords provided by Clemens Tempfer, Ruhr University of Bochum:
ovarian cancer, recurrent, chemotherapy, intraperitoneal
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action