Treating Peritoneal Carcinomatosis With PIPAC

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a feasibility study that aims to evaluate whether PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) is a safe and feasible treatment in Danish patients with peritoneal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Bau Mortensen
• Treatments: Cisplatin; Doxorubicin; Oxaliplatin

Criteria

Inclusion criteria

• Histological or cytological verified malignancy.

• Clinical or radiological evidence of peritoneal carcinomatosis.

• No indication for standard chemotherapy.

• Performance status 0-2 and life expectancy of more than 3 months.

• Age > 18 years.

• Written informed consent must be obtained according to the local Ethics Committee requirements.

Exclusion criteria

• Symptomatic small bowel obstruction (Total parenteral nutrition, nasogastric tube).

• Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.

• A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin.

• Renal impairment, defined as GFR < 50 ml/min, (Cockcroft-Gault Equation).

• Myocardial insufficiency, defined as NYHA class > 2.

• Impaired liver function defined as bilirubin ≥ 1,5 x UNL (upper normal limit).

• Inadequate haematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.

• Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.

• Previous intraabdominal chemotherapy or intraabdominal antibody therapy.