Overview

PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer

Status:
Completed
Trial end date:
2020-05-06
Target enrollment:
0
Participant gender:
All
Summary
The PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Ghent
Collaborators:
Candiolo Cancer Institute - IRCCS
Centre Hospitalier Universitaire Vaudois
Hopital Lariboisière
Kom Op Tegen Kanker
University Ghent
University Women's Hospital Tübingen
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
Inclusion Criteria:

- Phase I study: patients with advanced carcinomatosis from ovarian, breast, gastric, or
pancreatic origin. No alternative systemic treatment options are available.

- Age over 18 years

- Adequate performance status (Karnofsky index > 60%)

- Absence of intestinal or urinary obstruction

- Limited size of the majority of peritoneal tumor implants (< 5 mm)

- Absent or limited ascites

- Ability to understand the proposed treatment protocol and provide informed consent

- Expected life expectancy more than 6 months

- Laboratory data

- Serum creatinine ≤ 1.5 mg/dl or a calculated GFR (CKD-EPI) ≥ 60 mL/min/1.73 m²

- Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease

- Platelet count > 100.000/µl

- Hemoglobin > 9g/dl

- Neutrophil granulocytes > 1.500/ml

- No major blood coagulation disorders. Parameters within normal range.

- Absence of alcohol and/or drug abuse

- No other concurrent malignant disease

- Written informed consent

Exclusion Criteria:

- Pregnancy or breast feeding. Women who can become pregnant must ensure effective
contraception.

- Active bacterial, viral or fungal infection

- Active gastro-duodenal ulcer

- Parenchymal liver disease (any stage cirrhosis)

- Uncontrolled diabetes mellitus

- Psychiatric pathology affecting comprehension and judgement faculty

- General or local (abdominal) contra-indications for laparoscopic surgery

- Documented intolerance or allergy to paclitaxel

- Patients who receive other taxane therapy until three weeks before the first
experimental treatment