PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis (Nab-PIPAC)

University Hospitals (UH)

Status and phase

Active, not recruiting

Phase 1

Conditions

Peritoneal Carcinomatosis

Treatments

Drug: Cisplatin

Drug: Nab paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT04000906

2018-01327-Nab-PIPAC

Details and patient eligibility

About

Phase Ib trial including investigating the combination of nab-paclitaxel and cisplatin in patients diagnosed with peritoneal carcinomatosis related to pancreatic, oeso-gastric, ovarian cancer or primitive peritoneal mesothelioma.

Full description

Phase Ib trial investigating the combination of intraperitoneal Cisplatin (10.5 mg/m2) and Nab-paclitaxel (escalated dose from 7.5 mg/m2 to 70 mg/m2) administered by pressurized intraperitoneal aerosol chemotherapy (PIPAC) every 4-6 weeks for 3 cycles.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent as documented by signature
≥18 years,
psychologically able to follow the trial procedures
with peritoneal carcinomatosis from pancreatic, oesogastric, epithelial ovarian cancers or primitive peritoneal mesothelioma,
ECOG 0, 1 or 2,
Life expectancy > 3 months,
Not candidate for surgical cytoreduction and IP/HIPEC based on expert multidisciplinary board
who received at least one line of chemotherapy and for whom standard therapies have been exhausted or not feasible. patients with residual disease following the first line of therapy or Following secondary debulking are eligible.

Exclusion criteria

Predominant extra-peritoneal metastases at the discretion of the study team after discussion at the multidisciplinary board,
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 nab-paclitaxel,
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, severe hepatic (Serum total bilirubin > 1.5 mg/dl), 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.