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

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clemens Tempfer
• Treatments: Cisplatin; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. clinical and/or radiological evidence of PC,

2. age between 18 and 85 years with a diagnosis of recurrent ovarian cancer with disease progression after at least one line of previous intravenous chemotherapy with a platinum compound,

3. blood and electrolyte counts, liver, and renal function parameters within 10% of the normal range established in the respective laboratory of the study institution,

4. provision of written informed consent, and

5. postmenopausal status.

Exclusion Criteria:

1. extraabdominal metastatic disease, with the exception of isolated pleural carcinomatosis/effusion,

2. chemotherapy or surgery within the last four weeks prior to the first PIPAC application,

3. previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones,

4. a history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin,

5. severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction or severe cardiac arrhythmia,

6. immunocompromised status such as immunosuppressive therapy or a known disease of the immune system,

7. previous enrolment in the present study, and

8. previous intraabdominal chemotherapy or intraabdominal antibody therapy.