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Completed

NCT Number: NCT02604784

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

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.

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Candiolo, Turin, 10060, Italy

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Drug

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

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

Drug

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

Primary outcomes

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

    Time frame: 18 weeks

Secondary outcomes

  1. The overall survival (OS)

    Time frame: 30 months

  2. The degree of histological regression assessed by pathological review

    Time frame: 18 weeks

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

    Time frame: 30 months

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

    Time frame: 22 weeks

  5. The Peritoneal Carcinomatosis Index (PCI) before and after therapy

    Time frame: 18 weeks

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study 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

Acronym: PI-CaP

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2015
Registry last updated
Sep 17, 2020

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.

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