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NCT01809379 Clinical Trial

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

Recurrent Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01809379
Other study ID # PIPAC-OV1
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2013
Est. completion date September 2014

Study information
Verified date July 2022
Source Ruhr University of Bochum
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date September 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - at least 2 lines of previous chemotherapy - recurrent ovarian cancer - patient is mobile - informed consent Exclusion Criteria: - ileus - necessity of parenteral nutrition

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• chemotherapy with doxorubicin and cisplatin
intraperitoneal chemotherapy applied as an aerosol and under pressure

Locations
Country Name City State
Germany Ruhr University Bochum Bochum NRW

Sponsors (1)
Lead Sponsor Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other tumor apoptosis assessment, videolaparoscopy assessment of response, CA 125 assessment of response various measures of response to therapy on the clinical, biochemical, and histological level 6 months
Primary Clinical Benefit Rate The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria. 6 months
Secondary safety left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy complications postoperative until hospital discharge, re-admission to hospital, death 6 months
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