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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximally Tolerated Dose (MTD) of Abraxane
Timeframe: Within 14 weeks of the start of the treatment