Clinical trial NCT04000906: PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Peritoneal Carcinomatosis
Keywords: pancreatic cancer
oeso-gastric cancer
epithelial ovarian cancer
primitive peritoneal mesothelioma
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the maximal tolerated dose (MTD) of Nab paclitaxel (Abraxane®) administered IP by PIPAC in concomitance with cisplatin.
timeFrame: From the time of treatment randomization through 30 days following cessation of treatment
Secondary outcomes:
measure: Adverse events (AE) and serious adverse events (SAE)
timeFrame: D-1/D10 of each cycle
measure: The efficacy
timeFrame: D0 of each cycle
measure: The QoL
timeFrame: D-1/D10 of each cycle
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital, Lausanne
state: Vaud
city: Geneva
country: Switzerland
facility: University Hospital, Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Intidhar Labidi-Galy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: