PIPAC With Nab-paclitaxel And Cisplatin In Peritoneal Carcinomatosis

Study Overview

PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis

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.

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.

Peritoneal Carcinomatosis

DRUG: Nab paclitaxel
DRUG: Cisplatin

2018-01327-Nab-PIPAC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-05-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-05-23
First Submitted that Met QC Criteria 2019-06-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-05-24
First Posted (ACTUAL) 2019-06-27	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental Arm Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin	DRUG: Nab paclitaxel Dose escalation (7.5 mg/m2, 15 mg/m2, 25 mg/m2, 37.5 mg/m2, 52.5 mg/m2 and 70 mg/m2) DRUG: Cisplatin 10.5 mg/m2

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Experimental Arm

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin

DRUG: Nab paclitaxel

Dose escalation (7.5 mg/m2, 15 mg/m2, 25 mg/m2, 37.5 mg/m2, 52.5 mg/m2 and 70 mg/m2)

DRUG: Cisplatin

10.5 mg/m2

Primary Outcome Measures	Measure Description	Time Frame
Determine the maximal tolerated dose (MTD) of Nab paclitaxel (Abraxane®) administered IP by PIPAC in concomitance with cisplatin.	MTD is defined as the lowest dose level at which ≥33% of patients' experience dose limiting toxicity in accordance to CTCAE version 5.0 criteria.	From the time of treatment randomization through 30 days following cessation of treatment

Secondary Outcome Measures	Measure Description	Time Frame
Adverse events (AE) and serious adverse events (SAE)	AE and SAE with predefined toxicity criteria will be applied using CTCAE version 5.0 criteria, documented before and after each cycle of PIPAC treatment. Surgical complications will be assessed according to Clavien classification and comprehensive complication index (CCI)	D-1/D10 of each cycle
The efficacy	It will be assessed by the objective histological regression and objective tumor response rate (OTR) according to the new regression system for peritoneal cancer (PRGS, peritoneal regression grade score system). The objective response rate (ORR), the clinical benefit rate (CBR) as defined by RECIST version 1.1 criteria and the relevance of radiological response assessed by CT enterography (CT-PCI score).	D0 of each cycle
The QoL	QoL will be evaluated based on the EORTC questionnaire QLQ-C30 Version 3.0 and visual analogic scale for pain (VAS scale).	D-1/D10 of each cycle

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Intidhar Labidi-Galy, MD, PhD, University Hospital, Geneva

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lang N, Diciola A, Labidi-Galy I, Ris F, Di Marco M, Mach N, Petignat P, Toso C, Undurraga M, Hubner M. Nab-PIPAC: a phase IB study protocol of intraperitoneal cisplatin and nab-paclitaxel administered by pressurised intraperitoneal aerosol chemotherapy (PIPAC) in the treatment of advanced malignancies confined to the peritoneal cavity. BMJ Open. 2023 Jan 5;13(1):e067691. doi: 10.1136/bmjopen-2022-067691.

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Clinical Trial Record