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. 2018 Aug 29;3(3):20180118.
doi: 10.1515/pp-2018-0118. eCollection 2018 Sep 1.

Study protocol: phase 1 dose escalating study of Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) with oxaliplatin in peritoneal metastasis

Guowei Kim  1 , Hon Lyn Tan  2 , Elya Chen  3 , Siok Chin Teo  3 , Clarisse Jia Min Jang  3 , Jingshan Ho  2 , Yvonne Ang  2 , Natalie Yan Li Ngoi  2 , Cheng Ean Chee  2 , Bettina Lieske  1 , Asim Shabbir  1 , Ling-Zhi Wang  4 , Jimmy Bok Yan So  3 , Wei Peng Yong  2
Affiliations

Study protocol: phase 1 dose escalating study of Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) with oxaliplatin in peritoneal metastasis

Guowei Kim et al. Pleura Peritoneum. .

Abstract

Background: Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is a novel laparoscopic intraperitoneal chemotherapy technique, with advantages such as homogeneous distribution of aerosol and deeper tissue penetration. Thus far, PIPAC oxaliplatin has been administered at an arbitrary dose of 92 mg/m2.

Aim: We aim to determine the dose-related safety profile and tolerability of PIPAC oxaliplatin using an evidence-based approach. The secondary aim is to evaluate clinic-pathologic response and the pharmacokinetic profile.

Methods: This is a phase I 3+3 dose escalation study for gastric and colorectal cancer with predominant peritoneal metastasis starting at a dose of 45 mg/m2. Safety is assessed according to Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (version 4.0). Clinico-pathologic response is assessed using the Peritoneal Regression Grading Score, Peritoneal Cancer Index, and Response Evaluation Criteria In Solid Tumour criteria (version 1.1). Pharmacokinetic analysis is performed using Inductively Coupled Plasma-Mass Spectrometry assay. This trial is registered on ClinicalTrials.gov (NCT03172416).

Conclusions: This phase I study can provide the scientific basis to identify the optimal dose for PIPAC with oxaliplatin such that the benefits of this novel and promising intraperitoneal chemotherapy delivery technique can be maximized.

Keywords: PIPAC; dose escalation; oxaliplatin; peritoneal carcinomatosis; phase I; study protocol.

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Conflict of interest statement

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Figures

Figure 1:
Figure 1:
The 3+3 dose escalation study design.
See this image and copyright information in PMC

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