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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)

Primary Purpose

Peritoneal Carcinomatosis

Status

Completed

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose

Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose

About this trial

This is an interventional treatment trial for Peritoneal Carcinomatosis focused on measuring Pressurized Intra Peritoneal Air-flow Chemotherapy (PIPAC), Chemotherapy, Peritoneal Carcinomatosis

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

cohort A

cohort B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC.

Secondary Outcome Measures

The overall survival (OS)

The degree of histological regression assessed by pathological review

The median time to progression (TTP) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC

Measurement of clinical tumor response to therapy using FDG- Positron Emission Tomography (PET) according to PERCIST criteria (version 1.0).

The Peritoneal Carcinomatosis Index (PCI) before and after therapy

Full Information

NCT ID

NCT02604784

First Posted

November 3, 2015

Last Updated

September 16, 2020

Sponsor

Fondazione del Piemonte per l'Oncologia

1. Study Identification

Unique Protocol Identification Number

NCT02604784

Brief Title

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

Acronym

PI-CaP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

May 31, 2020 (Actual)

Study Completion Date

May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione del Piemonte per l'Oncologia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peritoneal Carcinomatosis

Keywords

Pressurized Intra Peritoneal Air-flow Chemotherapy (PIPAC), Chemotherapy, Peritoneal Carcinomatosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Two parallel cohorts according to patients characteristics Patient with indication for systemic standard chemotherapy will be accrued in Cohort A (for a Phase II repeated single dose PIPAC). Patient with no indication for sistemic standard chemotheralpy will be accrued in Cohort B ( for a Phase, single ascending dose PIPAC)

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cohort A

Arm Type

Experimental

Arm Description

Arm Title

cohort B

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose

Other Intervention Name(s)

Cisplatin + Doxorubicin in ovarian, gastric cancer and in primary peritoneal tumors; or Oxaliplatin in colorectal cancer

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose

Other Intervention Name(s)

Cisplatin + Doxorubicin in ovarian, gastric cancer and in primary peritoneal tumors; or Oxaliplatin in colorectal cancer

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC.

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

The overall survival (OS)

Time Frame

30 months

Title

The degree of histological regression assessed by pathological review

Time Frame

18 weeks

Title

The median time to progression (TTP) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC

Time Frame

30 months

Title

Measurement of clinical tumor response to therapy using FDG- Positron Emission Tomography (PET) according to PERCIST criteria (version 1.0).

Time Frame

22 weeks

Title

The Peritoneal Carcinomatosis Index (PCI) before and after therapy

Time Frame

18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment

City

Candiolo

State/Province

Turin

ZIP/Postal Code

10060

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

34070561

Citation

Robella M, Berchialla P, Borsano A, Cinquegrana A, Ilari Civit A, De Simone M, Vaira M. Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases. Int J Environ Res Public Health. 2021 May 25;18(11):5656. doi: 10.3390/ijerph18115656.

Results Reference

derived

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