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

NCT02735928 | Completed

• 1 other identifier: PARROT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Epithelial Cancer Recurrent; Platinum-resistant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The median time to progression according to RECIST criteria after three cycles of PIPAC with cisplatin

  1 Year

• Fagotti score, as assessed by laparoscopy

  1 Year

• The degree of histological regression assessed by pathological review of repeated peritoneal biopsies

  1 Year

• The proportion of women with a reduction of serum CA-125 of at least 50% after PIPAC

  1 Year

• Evaluation of the Quality Of Life (QOL) on the basis of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires

  1 year

Study Arms (1)

PIPAC

EXPERIMENTAL

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

Device: Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin

Interventions

Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin 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).

Also known as: PIPAC

PIPAC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

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

  PMID: 24378877 RESULT

• 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.

  PMID: 25701703 RESULT

• 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.

  PMID: 24849521 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: April 13, 2016
• Study Start: January 1, 2016
• Primary Completion: June 15, 2021
• Study Completion: June 16, 2022
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)