Treating peritoneal metastases with pressurized chemotherapy - the PIPAC-2 trial

Phase 1

Active, not recruiting

• Conditions: Peritoneal carcinomatosis (PC); MedDRA version: 19.0Level: LLTClassification code 10068069Term: Peritoneal carcinomatosisSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003394-18-DK
• Lead Sponsor: Michael Bau Mortensen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-02
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 137

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified