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)

Fondazione del Piemonte per l'Oncologia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Peritoneal Carcinomatosis

Treatments: Drug: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose; Drug: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02604784

015-IRCCS-27F-1

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

cohort A

Experimental group

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.

Treatment:

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

cohort B

Experimental group

Description:

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.

Treatment:

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