PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04000906

Studienbeginn:
November 2020

Letztes Update:
20.12.2022

Wirkstoff:
nab paclitaxel, Cisplatin

Indikation (Clinical Trials):
Carcinoma, Peritoneal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
University Hospital, Geneva

Collaborator:
-

Studienleiter

Intidhar Labidi-Galy, MD, PhD
Principal Investigator
University Hospital, Geneva

Kontakt

Intidhar Labidi-Galy, MD, PhD
Kontakt:
Phone: 0041 22 372 4014
E-Mail: intidhar.labidi-galy@hcuge.ch» Kontaktdaten anzeigen

Catherine Raimond, PharmD
Kontakt:
Phone: 0041 22 37 22 908
E-Mail: catherine.raimond@hcuge.ch» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

University Hospital, Lausanne
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Antonella Diciolla, MD
Phone: 0041 79 55 63 011
E-Mail: Antonella.Diciolla@chuv.ch» Ansprechpartner anzeigen

University Hospital, Geneva
1211 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Intidhar Labidi-Galy, MD, PhD
Phone: 0041 22 372 4014
E-Mail: intidhar.labidi-galy@hcuge.ch

Catherine Raimond, PharmD
Phone: 0041 22 37 22 908
E-Mail: catherine.raimond@hcuge.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Determine the maximal tolerated dose (MTD) of Nab paclitaxel (Abraxane®) administered IP by PIPAC in concomitance with cisplatin. (Time Frame - From the time of treatment randomization through 30 days following cessation of treatment):
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.

Secondary outcome:

1. Adverse events (AE) and serious adverse events (SAE) (Time Frame - D-1/D10 of each cycle):
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)

2. The efficacy (Time Frame - D0 of each cycle):
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).

3. The QoL (Time Frame - D-1/D10 of each cycle):
QoL will be evaluated based on the EORTC questionnaire QLQ-C30 Version 3.0 and visual analogic scale for pain (VAS scale).

Geprüfte Regime

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)
Cisplatin:
10.5 mg/m2

Quelle: ClinicalTrials.gov

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