A Study With Intraperitoneal Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Peritoneal Carcinomatosis
Status:
Completed
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
Fifteen women with recurrent ovarian cancer will be treated by an intraperitoneal
chemotherapy with cisplatin and doxorubicin in three escalating dosage schedules. The aim of
the study is to evaluate the safety and tolerability of doxorubicin and cisplatin every 4
weeks for three courses using a three-group, dose-escalation protocol with fixed
dose-density. The time Frame for the assessment of the Primary outcome is therefore 12 weeks.
Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria. The study
hypothesis is that local and systemic toxicity will increase with increasing dosage of
cisplatin and doxorubicin during three repeated PIPAC courses with no CTCAE grade 4 and 5
events in any treatment group.