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

Primary Purpose

Ovarian Epithelial Cancer Recurrent, Platinum-resistant

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Epithelial Cancer Recurrent

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Catholic University of Sacred Heart

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PIPAC

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Fagotti score, as assessed by laparoscopy
The degree of histological regression assessed by pathological review of repeated peritoneal biopsies
The proportion of women with a reduction of serum CA-125 of at least 50% after PIPAC
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

Full Information

First Posted
February 8, 2016
Last Updated
November 30, 2022
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT02735928
Brief Title
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Epithelial Cancer Recurrent, Platinum-resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIPAC
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin
Other Intervention Name(s)
PIPAC
Intervention Description
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).
Primary Outcome Measure Information:
Title
Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin
Description
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
Time Frame
12-18 weeks
Secondary Outcome Measure Information:
Title
The median time to progression according to RECIST criteria after three cycles of PIPAC with cisplatin
Description
From the last chemotherapy cycle to the first clinical-radiological signs of disease relapse
Time Frame
1 Year
Title
Fagotti score, as assessed by laparoscopy
Time Frame
1 Year
Title
The degree of histological regression assessed by pathological review of repeated peritoneal biopsies
Time Frame
1 Year
Title
The proportion of women with a reduction of serum CA-125 of at least 50% after PIPAC
Time Frame
1 Year
Title
Evaluation of the Quality Of Life (QOL) on the basis of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires
Description
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
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24378877
Citation
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.
Results Reference
result
PubMed Identifier
25701703
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/j.ygyno.2015.02.009. Epub 2015 Feb 18.
Results Reference
result
PubMed Identifier
24849521
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 single-institution experience. Ann Surg Oncol. 2014 Nov;21(12):3970-7. doi: 10.1245/s10434-014-3783-6. Epub 2014 May 22.
Results Reference
result

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

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