Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor (PARROT)

Catholic University of the Sacred Heart

Status: Completed

Conditions: Platinum-resistant; Ovarian Epithelial Cancer Recurrent

Treatments: Device: Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02735928

PARROT

Details and patient eligibility

About

Patients with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a combination of cisplatin and doxorubicin.

Full description

This study aims to investigate the therapeutic efficacy of PIPAC using cisplatin and doxorubicin in women with first recurrent resistance 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/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin

Enrollment: 40 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients affected by first or second platinum resistant epithelial ovarian tumor recurrence.
• ECOG-performance status ≤ 3.
• Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count > 1500 / mm3, platelets > 150 000/μl, creatinine clearance > 60 mL / min according to Cockroft formula).
• Patient-compliant and psychologically able to follow the trial procedures.

Exclusion criteria

• Non-epithelial ovarian cancer or borderline ovarian tumor.
• Pregnancy or breastfeeding.
• Patients affected by major depressive disorder even in treatment or minor mood disorders.
• Patients with severe impairment of respiratory, hepatic or renal function.
• Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
• Patients with bowel obstruction.
• Inadequate bone marrow, liver, kidney function.
• No clear-peritoneal disease at surgical exploration.
• Patients with ascites >2000 cc (CT-Scan)
• Patients who have already made third line chemotherapy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

PIPAC

Experimental group

Description:

PIPAC stands for Pressurized IntraPeritoneal Aerosol Chemotherapies. Enrolled patients will undergo to explorative laparoscopy as usual and PC index will be determined according to Fagotti score (PIV). Pathological response will be determined by serial peritoneal biopsies. Then a pressurized aerosol containing cisplatin followed by doxorubicin will be applied via a nebulizer. The PIPAC procedure can be repeated after 4-6 weeks until progression or limiting toxicity

Treatment:

Device: Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin