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
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Recurrence
• Recurrent Ovarian Cancer

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