PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer (NCT03304210) | Clinical Trial Compass
CompletedPhase 1
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
Belgium20 participantsStarted 2017-09-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Maximally Tolerated Dose (MTD) of Abraxane
Timeframe: Within 14 weeks of the start of the treatment