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
Condition: Peritoneal Carcinomatosis
MeSH terms: Carcinoma; Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose; Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Cisplatin + Doxorubicin in ovarian, gastric cancer and in primary peritoneal tumors; or Oxaliplatin in colorectal cancer; Cisplatin + Doxorubicin in ovarian, gastric cancer and in primary peritoneal tumors; or Oxaliplatin in colorectal cancer
Intervention MeSH terms: Cisplatin; Doxorubicin; Liposomal doxorubicin; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Pressurized Intra Peritoneal Air-flow Chemotherapy (PIPAC); Chemotherapy; Peritoneal Carcinomatosis