A Phase 2 interventional study of chemotherapy with doxorubicin and cisplatin in Recurrent Ovarian Cancer, sponsored by Ruhr University of Bochum. Completed at 1 site in Germany. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-08.
Sponsored by Ruhr University of Bochum · Phase 2, Interventional, and Treatment
This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer
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.
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's enrollment of 69 is above the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Ruhr University of Bochum is the lead sponsor of 126 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
Drug pages: Doxorubicin · Cisplatin
intraperitoneal chemotherapy applied as an aerosol and under pressure
Also known as: CISPLATIN Teva, Adrimedac
Clinical Benefit Rate
The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.
Time frame: 6 months
safety
left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy complications postoperative until hospital discharge, re-admission to hospital, death
Time frame: 6 months
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
Time frame: 6 months
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Doxorubicin · Cisplatin