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

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ClinicalTrials.gov Identifier: NCT02735928
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Recurrent Platinum-resistant Device: Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2021


Arm Intervention/treatment
Experimental: 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
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 7.5 mg/m2 body surface in 150 ml NaCl 0.9 % followed by doxorubicin at a dose of 1.5 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 Name: PIPAC




Primary Outcome Measures :
  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 Outcome Measures :
  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. PCI, 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735928


Locations
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Italy
Catholic University of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Giovanni Scambia, Professor    +39 0630156279    clinicaltrials@rm.unicatt.it   
Contact: Federica Nardelli, MD    +39-06-30156279    nardelli.fede@gmail.com   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Publications of Results:
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Responsible Party: Prof. Giovanni Scambia, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02735928    
Other Study ID Numbers: PARROT
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action