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

Ovarian Epithelial Cancer Recurrent Clinical Trial

— PARROT  

Official title:

Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase I-II Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735928
• Other study ID #: PARROT
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: June 16, 2022

Study information

• Verified date: November 2023
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 16, 2022
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Epithelial Cancer Recurrent
• Platinum-resistant

Intervention

Device:
• Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin
After insufflation of a 12 mmHg of capnoperitoneum at 37 °C, two balloon trocars will be placed. Parietal biopsies will be taken and ascites (< 500cc) will be removed. A nebulizer will be connected to a high-pressure injector and will be inserted into the abdomen through a trocar. A pressurized aerosol containing cisplatin at a dose of 10.5 mg/m2 body surface in 150 ml NaCl 0.9 % followed by doxorubicin at a dose of 2.1 mg/m2 body surface in a 50 ml NaCl 0.9% solution will be applied via a nebulizer immediately. Then, the system will be kept in steady-state for 30 min (i.e.: application time).

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Fagotti A, Petrillo M, Costantini B, Fanfani F, Gallotta V, Chiantera V, Turco LC, Bottoni C, Scambia G. Minimally invasive secondary cytoreduction plus HIPEC for recurrent ovarian cancer: a case series. Gynecol Oncol. 2014 Feb;132(2):303-6. doi: 10.1016/ — View Citation

Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016 — View Citation

Vizzielli G, Costantini B, Tortorella L, Petrillo M, Fanfani F, Chiantera V, Ercoli A, Iodice R, Scambia G, Fagotti A. Influence of intraperitoneal dissemination assessed by laparoscopy on prognosis of advanced ovarian cancer: an exploratory analysis of a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin	Evaluation of target lesions will be done as follows: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase	12-18 weeks
Secondary	The median time to progression according to RECIST criteria after three cycles of PIPAC with cisplatin	From the last chemotherapy cycle to the first clinical-radiological signs of disease relapse	1 Year
Secondary	Fagotti score, as assessed by laparoscopy		1 Year
Secondary	The degree of histological regression assessed by pathological review of repeated peritoneal biopsies		1 Year
Secondary	The proportion of women with a reduction of serum CA-125 of at least 50% after PIPAC		1 Year
Secondary	Evaluation of the Quality Of Life (QOL) on the basis of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires	Quality of life will be assess using the EORTC quality of life questionnaire core-36 (QLQC-30) and the ovarian cancer-specific quality of life questionnaire (QLQ-Ov28).These will be complete before and after the first, second, and third PIPAC applications	1 year