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