Clinical trial · Interventional
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
Intraperitoneal Aerosolization of Albumin-stabilized Paclitaxel Nanoparticles for Stomach, Pancreas, Breast and Ovarian Cancer
NCT03304210CI-TRIAL-00071124PIPAC-nabpaccompletedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Stage IIIB | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage IIIc | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Ovarian Cancer Stage IIIB | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Ovarian Cancer Stage IIIC | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Ovarian Cancer Stage IV | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Pancreas Cancer, Stage III | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Pancreas Cancer, Stage IV | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIPAC with Abraxane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Abraxane 35 mg/m²
- description
- PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
- interventionNames
- Drug: PIPAC with Abraxane
- type
- EXPERIMENTAL
- label
- Abraxane 70 mg/m²
- description
- PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
- interventionNames
- Drug: PIPAC with Abraxane
- type
- EXPERIMENTAL
- label
- Abraxane 90 mg/m²
- description
- PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDVan De Sande L, Graversen M, Hubner M, Pocard M, Reymond M, Vaira M, Cosyns S, Willaert W, Ceelen W. Intraperitoneal aerosolization of albumin-stabilized paclitaxel nanoparticles (Abraxane) for peritoneal carcinomatosis - a phase I first-in-human study. Pleura Peritoneum. 2018 Jun 8;3(2):20180112. doi: 10.1515/pp-2018-0112. eCollection 2018 Jun 1. PMID 30911657
- RESULTCeelen W, Sandra L, de Sande LV, Graversen M, Mortensen MB, Vermeulen A, Gasthuys E, Reynders D, Cosyns S, Hoorens A, Willaert W. Phase I study of intraperitoneal aerosolized nanoparticle albumin based paclitaxel (NAB-PTX) for unresectable peritoneal metastases. EBioMedicine. 2022 Aug;82:104151. doi: 10.1016/j.ebiom.2022.104151. Epub 2022 Jul 15. PMID 35843174