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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort A | Experimental | 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. |
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| cohort B | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The overall survival (OS) | 30 months | |
| The degree of histological regression assessed by pathological review | 18 weeks | |
| The median time to progression (TTP) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment | Candiolo | Turin | 10060 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34070561 | Derived | 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. |
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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)
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| 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. |
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| 30 months |
| Measurement of clinical tumor response to therapy using FDG- Positron Emission Tomography (PET) according to PERCIST criteria (version 1.0). | 22 weeks |
| The Peritoneal Carcinomatosis Index (PCI) before and after therapy | 18 weeks |
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D004317 | Doxorubicin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
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