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

NCT ID: NCT02735928

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2022-06-16

Brief 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.

Detailed 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

Conditions

Ovarian Epithelial Cancer Recurrent; Platinum-resistant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PIPAC

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

Group Type: EXPERIMENTAL

Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

PIPAC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Prof. Giovanni Scambia

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Sacred Heart

Rome, , Italy

Countries

Italy

References

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/j.ygyno.2013.12.028. Epub 2013 Dec 27.

Reference Type: RESULT

PMID: 24378877 (View on PubMed)

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/j.ygyno.2015.02.009. Epub 2015 Feb 18.

Reference Type: RESULT

PMID: 25701703 (View on PubMed)

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 single-institution experience. Ann Surg Oncol. 2014 Nov;21(12):3970-7. doi: 10.1245/s10434-014-3783-6. Epub 2014 May 22.

Reference Type: RESULT

PMID: 24849521 (View on PubMed)

Other Identifiers

PARROT

Identifier Type: -

Identifier Source: org_study_id