PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
Condition: Peritoneal Carcinomatosis; Ovarian Cancer Stage IIIB; Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV; Breast Cancer Stage IIIB; Breast Cancer Stage IIIc; Breast Cancer Stage IV; Stomach Cancer Stage III; Stomach Cancer Stage IV With Metastases; Pancreas Cancer, Stage III; Pancreas Cancer, Stage IV
MeSH terms: Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Pancreatic Neoplasms; Carcinoma; Peritoneal Neoplasms; Stomach Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome
Intervention: PIPAC with Abraxane
Intervention description: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
Intervention MeSH terms: Albumin-Bound Paclitaxel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PIPAC; Peritoneal carcinomatosis; Ovarian cancer; Pharmacokinetics; Pharmacodynamics; Safety and efficacy; Abraxane; Breast cancer; Pancreas cancer; Stomach cancer

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.
    

Eligibility 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