Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors (PI-CaP)

September 16, 2020 updated by: Fondazione del Piemonte per l'Oncologia

Feasibility, Efficacy and Safety of Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) With Oxaliplatin, Cisplatin and Doxorubicin in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancers and Primary Tumors of the Peritoneum: An Open-label, Two-arms, Phase I-II Clinical Trial. PI-CaP

Single center, open label, phase I-II, non-randomized, two-cohort, repeated single dose study to explore the feasibility, efficacy, safety, and Overall Response Rate (ORR) of oxaliplatin, or cisplatin and doxorubicin when given as a pressurized intraperitoneal chemotherapy (PIPAC) to patients (men and women) with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and in primary cancers of peritoneum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Turin
      • Candiolo, Turin, Italy, 10060
        • Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical and pathological confirmation of peritoneal carcinomatosis from gastric, colorectal and ovarian cancers or primary peritoneal tumors.
  • Patients aged between 18 and 78 years.
  • Performance status sec. ECOG ≤ 2
  • Disease progression/relapse after at least one line of previous i.v. standard chemotherapy in gastric cancer and primary peritoneal tumors and two lines in colorectal and ovarian cancers.
  • Patients with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and primary peritoneal cancers not eligible to cytoreductive surgery +/- HIPEC.
  • Blood and electrolyte counts, liver, renal and cardiopulmonary function parameters within 10% of the normal range.
  • Written informed consent.
  • Tumor mass present on CT-scan in order to allow tumor response assessment with RECIST-criteria.

Exclusion Criteria:

  • Extra-abdominal metastatic disease, with the exception of isolated pleural carcinomatosis.
  • Bowel obstruction.
  • Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
  • Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
  • Creatinine clearance < 60 ml /min.
  • Pregnancy.
  • Previous treatment reaching the maximum cumulative dose of doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines and anthracenediones.
  • Known allergy to cisplatin or other platinum-containing compounds or to doxorubicin.
  • Patients of both sexes who do not conduct complete abstinence from heterosexual relationships or agree to use an effective clinically acceptable method (with failure rate <1%) during the study and the following 6 months after the last treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cohort A
Cohort A: For patients that have indication for systemic therapy with standard chemotherapy. This cohort has a phase II design; the Objective Response Rate (ORR) will be evaluated according to the RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC with Cisplatin (7.5 mg/m²) + Doxorubicin (1.5 mg/m2 ) or Oxaliplatin (92 mg/m2) according to the primary cancer, in association with standard systemic chemotherapy.
Drug: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose
An open access with a midline 5-6 cm incision is performed and a single-port platform is positioned. A 12 mm Hg CO2 pneumoperitoneum is inflated. PC extent is evaluated according to Peritoneal Cancer Index (PCI) and peritoneal biopsies are taken. A nebulizer is connected to an intravenous high-pressure injector and inserted into the peritoneal cavity; the tightness of the abdomen has to be documented with a CO2 zero-flow. The laparoscopic camera and the nebulizer are maintained in position by a self-retaining retractor (Thompson). A pressurized aerosol containing drugs is delivered. Standard dosage of drugs for each PIPAC: Cisplatin (7.5 mg/m²) + Doxorubicin (1.5 mg/m²) or Oxaliplatin (92 mg/m²) The capnoperitoneum is then maintained for 30 minutes at 37°C. At the end, the aerosol is exsufflated through two sequential micro-particle filters into the air-waste system of the hospital.
Other Names:
  • Cisplatin + Doxorubicin in ovarian, gastric cancer and in primary peritoneal tumors; or Oxaliplatin in colorectal cancer
Experimental: cohort B
Cohort B: For patients that have not indication for systemic therapy with standard chemotherapy. This cohort has a phase I design; with a dose-escalation design the maximum tolerated doses and recommended doses of Cisplatin + Doxorubicin and Oxaliplatin (according to the pathology) administered through PIPAC in patients with peritoneal carcinomatosis will be evaluated.
Drug: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose
An open access with a midline 5-6 cm incision is performed and a single-port platform is positioned. A 12 mm Hg CO2 pneumoperitoneum is inflated. PC extent is evaluated according to Peritoneal Cancer Index (PCI) and peritoneal biopsies are taken. A nebulizer is connected to an intravenous high-pressure injector and inserted into the peritoneal cavity; the tightness of the abdomen has to be documented with a CO2 zero-flow. The laparoscopic camera and the nebulizer are maintained in position by a self-retaining retractor (Thompson). A pressurized aerosol containing drugs is delivered. Escalating dosage of drugs for PIPAC: Cisplatin + Doxorubicin (from 15 mg/m² + 3 mg/m² to 100 mg/m² + 30 mg/m²) or Oxaliplatin (from 92 mg/m² to 300mg/m²).The capnoperitoneum is then maintained for 30 minutes at 37°C. At the end, the aerosol is exsufflated through two sequential micro-particle filters.
Other Names:
  • Cisplatin + Doxorubicin in ovarian, gastric cancer and in primary peritoneal tumors; or Oxaliplatin in colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC.
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The overall survival (OS)
Time Frame: 30 months
30 months
The degree of histological regression assessed by pathological review
Time Frame: 18 weeks
18 weeks
The median time to progression (TTP) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC
Time Frame: 30 months
30 months
Measurement of clinical tumor response to therapy using FDG- Positron Emission Tomography (PET) according to PERCIST criteria (version 1.0).
Time Frame: 22 weeks
22 weeks
The Peritoneal Carcinomatosis Index (PCI) before and after therapy
Time Frame: 18 weeks
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione del Piemonte per l'Oncologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 015-IRCCS-27F-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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