Skip to main content
OpenTrials
Completed

NCT Number: NCT02735928

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Epithelial Cancer Recurrent Platinum-resistant

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Sacred Heart

Rome, 00168, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: PIPAC

Primary outcomes

  1. Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin

    Time frame: 12-18 weeks

    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

Secondary outcomes

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

    Time frame: 1 Year

    From the last chemotherapy cycle to the first clinical-radiological signs of disease relapse

  2. Fagotti score, as assessed by laparoscopy

    Time frame: 1 Year

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

    Time frame: 1 Year

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

    Time frame: 1 Year

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

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study 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

Acronym: PARROT

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Apr 13, 2016
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.