Phase 1
N=20
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
Peritoneal Carcinomatosis · Ovarian Cancer Stage IIIB · Ovarian Cancer Stage IIIC · Ovarian Cancer Stage IV · Breast Cancer Stage IIIB
Bottom Line
View on ClinicalTrials.gov: NCT03304210 ↗Enrolled (actual)
20
Serious AEs
65.0%
Results posted
Nov 2023
Primary outcome: Primary: Maximally Tolerated Dose (MTD) of Abraxane — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PIPAC with Abraxane (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Ghent
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximally Tolerated Dose (MTD) of Abraxane |
0; 0; 0; 0; 0 | — |
| SECONDARY Surgical Morbidity |
2; 2; 3; 3; 10 | — |
| SECONDARY Maximum Plasma Concentration of Abraxane |
58; 138; 101; 157; 184 | — |
| SECONDARY Area Under The Curve (AUC) of Abraxane |
585; 962; 813; 1658; 2002 | — |
| SECONDARY Histological Response Via Peritoneal Regression Grading Scoring (PRGS) |
0; 1; 1; 0; 7 | — |
| SECONDARY Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 |
0; 0; 1; 1; 4; 0 | — |
| SECONDARY Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 |
0; 1; 1; 2; 3; 0 | — |
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 ( 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
Data sourced from ClinicalTrials.gov (NCT03304210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.