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
18 Years
80 Years
Female
Recurrent Ovarian Cancer
Trial Information
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
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.
Inclusion Criteria:
- at least 2 lines of previous chemotherapy
- recurrent ovarian cancer
- patient is mobile
- informed consent
Exclusion Criteria:
- ileus
- necessity of parenteral nutrition
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical Benefit Rate
Outcome Description:
The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Clemens Tempfer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Runr University Bochum
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
PIPAC-OV1
NCT ID:
NCT01809379
Start Date:
February 2013
Completion Date:
February 2014
Related Keywords:
- Recurrent Ovarian Cancer
- ovarian cancer, recurrent, chemotherapy, intraperitoneal
- Ovarian Neoplasms
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