Treating Peritoneal Carcinomatosis With PIPAC

Launched by MICHAEL BAU MORTENSEN · Dec 18, 2014

Keywords

ClinConnect Summary

Peritoneal carcinomatosis (PC) represents end stage disease in many types of cancer (e.g. gastric, pancreatic, liver, colo-rectal, ovarian) and the majority of patients with PC will die from their disease within 6 months. Platinum-based systemic chemotherapy (SC) may prolong survival in selected patients, but poor performance status and low response rates have led to conservative (nihilistic) treatment strategies in these patients. However, patients with PC who are in good condition, and with a remaining life expectancy of more than a few months, may still have an unmet need for additional ...

Gender

ALL

Eligibility 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.

Trial Officials