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

Phase 1

Completed

• Conditions: Peritoneal Carcinomatosis
• Interventions: Drug: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose; Drug: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose

• Registration Number: NCT02604784
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-13
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort B	Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose	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.
cohort A	Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC.	18 weeks

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment; 🇮🇹 Candiolo, Turin, Italy