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

NCT ID: NCT01809379

Last Updated: 2022-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Recurrent Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

chemotherapy with doxorubicin and cisplatin

Intervention Type DRUG

intraperitoneal chemotherapy applied as an aerosol and under pressure

Interventions

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chemotherapy with doxorubicin and cisplatin

intraperitoneal chemotherapy applied as an aerosol and under pressure

Intervention Type DRUG

Other Intervention Names

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CISPLATIN Teva, Adrimedac

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* ileus
* necessity of parenteral nutrition
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Clemens Tempfer

Prof. Dr. med. Clemens Tempfer, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clemens Tempfer, MD

Role: PRINCIPAL_INVESTIGATOR

Runr University Bochum

Locations

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Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 25701703 (View on PubMed)

Other Identifiers

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PIPAC-OV1

Identifier Type: -

Identifier Source: org_study_id

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