Status:
COMPLETED
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Kom Op Tegen Kanker
University Ghent
Conditions:
Peritoneal Carcinomatosis
Ovarian Cancer Stage IIIB
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ch...
Detailed Description
Over 85% of women with ovarian cancer (OC) will develop a peritoneal recurrence after initial therapy. The prognosis of patients with recurrent disease is poor, with a median survival ranging from 12 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03304210
Start Date
September 16 2017
End Date
May 6 2020
Last Update
November 7 2023
Active Locations (1)
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1
UZ Ghent
Ghent, East-Flanders, Belgium, 9000