A Study With Intraperitoneal Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Peritoneal Carcinomatosis

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions
Ovarian Cancer
Interventions
DRUG

Cisplatin and doxorubicin

The first 5 patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 2.25 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 11.25 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 3 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 15 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. This schedule represents a three-step, 50% dose-escalation. Dose density will not be changed.

PROCEDURE

Cisplatin and doxorubicin

intraperitoneal chemotherapy with cisplatin and doxorubicin in a dose-escalation scheme

Trial Locations (1)

44625

Ruhr University Bochum, Germany, Marienhospital Herne, Herne

All Listed Sponsors
lead

Clemens Tempfer

OTHER

NCT02475772 - A Study With Intraperitoneal Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Peritoneal Carcinomatosis | Biotech Hunter | Biotech Hunter