Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer

Ruhr University of Bochum

Status and phase: Completed; Phase 2

Conditions: Recurrent Ovarian Cancer

Treatments: Drug: chemotherapy with doxorubicin and cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01809379

PIPAC-OV1

Details and patient eligibility

About

This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

Full description

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.

Enrollment: 69 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 2 lines of previous chemotherapy
• recurrent ovarian cancer
• patient is mobile
• informed consent

Exclusion criteria

• ileus
• necessity of parenteral nutrition

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

intraperitoneal chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: chemotherapy with doxorubicin and cisplatin