Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol Chemotherapy -

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study, where the efficacy of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) against peritoneal metastases will be evaluated. Furthermore, this study will focus on the best evaluation method, where both Quality of Life questionnaires, repeated histology, cytology and MRI will be used.

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

Details

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

Criteria

Inclusion Criteria:

• Histological or cytological verified gastrointestinal-, ovarian- or primary peritoneal malignancy (based on tissue from the primary tumor and/or its metastases).

• Ovarian cancer patients must be platinum resistant and have completed at least one line of chemotherapy for platinum resistant disease.

• Radiological, histological or cytological evidence of PC.

• No indication for CRS and HIPEC (according to National Guidelines).

• Performance status 0-1.

• No more than a single extra-peritoneal metastasis.

• Age > 18 years.

• Females must be post-menopausal

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

Exclusion Criteria:

• Symptomatic small bowel obstruction (i.e. 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 platinum containing compounds or doxorubicin.

• Renal impairment, defined as GFR < 40 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 hematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x109/l.