NAB-PIPAC: A phase IB trial of intraperitoneal cisplatin and Nab-Paclitaxel administered by pressurized intraperitoneal aerosol chemotherapy (PIPAC) in the treatment of advanced malignancies confined to the peritoneal cavity
Indication :

Peritoneal carcinomatosis from pancreatic, oesogastric, epithelial ovarian cancers or primitive peritoneal mesothelioma


Sponsor :

Hôpitaux universitaires de Genève (HUG)


Phase :

I


Ligne :

Après traitements standards/Si patient inéligible pour traitements standards


Traitement :

nab-paclitaxel and cisplatin (administered by PIPAC)


Site :

HUG


Contact(s) :
Dre Intidhar Labidi-Galy
Investigateur Principal

Hôpitaux universitaires de Genève
Oncologie

Rue Gabrielle-Perret Gentil 4
Genève
1211

+41 79 55 34 976
intidhar.labidi-galy@hcuge.ch
Catherine Raimond
Coordinatrice

HUG - unité de recherche clinique DFDL
Oncologie

Rue Gabrielle Perret-Gentil 4
Genève
1211

+41 79 55 35 603
catherine.raimond@hcuge.ch

Primary objective :

To determine the maximum tolerated dose (MTD) and the safety profile of nab-paclitaxel and cisplatin administered by PIPAC in accordance to CTCAE v5.0


Inclusion criteria :
  • Informed Consent as documented by signature
  • Age ≥18 years
  • Who are psychologically able to follow the trial procedures
  • With malignant disease confined to the abdominal cavity without parenchymatous metastatic disease (peritoneal carcinomatosis) from pancreatic, oesogastric, epithelial ovarian cancers (platinum resistant only) or primitive peritoneal mesothelioma
  • Not candidate for surgical cytoreduction and IP/HIPEC based on expert multidisciplinary board
  • For whom standard therapies have been exhausted or not feasible (>1 line of treatment for platinum resistant epithelial ovarian carcinoma, oesgastric carcinoma, pancreatic carcinoma and primitive peritoneal mesothelioma)
  • ECOG 0, 1 or 2
  • Life expectancy > 3 months

Exclusion criteria :
  • Extra-abdominal and intra-abdominal parenchymatous metastatic disease, with the exception of isolated pleural carcinomatosis/effusion or lymph node
  • Bowel obstruction, active gastro-duodenal ulcer or ongoing abdominal infection (bacterial, viral or fungal)
  • Chemotherapy or surgery within the last two weeks prior to enrollment
  • Previous intra-abdominal chemotherapy
  • General or local (abdominal) contra-indications for laparoscopic surgery
  • Known allergy to cisplatin or other platinum-containing compounds or to compounds of similar chemical or biologic composition of nab-paclitaxel
  • Progression while under or within 6 weeks of treatement by platinum
  • Severe renal impairment (calculated GFR (CKD-EPI) < 60 mL/min/1.73 m2)
  • Myelosuppression (platelet count < 100.000/μl, hemoglobin < 9g/dl, neutrophil granulocytes < 1.500/ml)
  • International Normalized Ratio (INR)  2
  • Hepatic impairment (serum total bilirubin  1.5 mg/dl, AST/ALT >1.5 x ULN)
  • Severe respiratory or neurologic impairment (grade 3)
  • Severe myocardial insufficiency (NYHA class >2), recent myocardial infarction, severe arrhythmias
  • Pregnancy or breastfeeding, women who can become pregnant must ensure effective contraception
  • Known or suspected non-compliance, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator