Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases

Manuela Robella, Paola Berchialla, Alice Borsano, Armando Cinquegrana, Alba Ilari Civit, Michele De Simone and Marco Vaira
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Manuela Robella: Unit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, Italy
Paola Berchialla: Department of Clinical and Biological Sciences, University of Turin, 10124 Turin, Italy
Alice Borsano: Unit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, Italy
Armando Cinquegrana: Unit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, Italy
Alba Ilari Civit: Unit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, Italy
Michele De Simone: Unit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, Italy
Marco Vaira: Unit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, Italy

IJERPH, 2021, vol. 18, issue 11, 1-9

Abstract: Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is a novel laparoscopic intraperitoneal chemotherapy approach offered in selected patients affected by non-resectable peritoneal carcinomatosis. Drugs doses currently established for nebulization are very low: oxaliplatin (OXA) 120 mg/sm, cisplatin (CDDP) 10.5 mg/sm and doxorubicin (DXR) 2.1 mg/sm. A model-based approach for dose-escalation design in a single PIPAC procedure and subsequent dose escalation steps is planned. The starting dose of oxaliplatin is 100 mg/sm with a maximum estimated dose of 300 mg/sm; an escalation with overdose and under-dose control (for probability of toxicity less than 16% in case of under-dosing and probability of toxicity greater than 33% in case of overdosing) will be further applied. Cisplatin is used in association with doxorubicin: A two-dimensional dose-finding design is applied on the basis of the estimated dose limiting toxicity (DLT) at all combinations. The starting doses are 15 mg/sm for cisplatin and 3 mg/sm for doxorubicin. Safety is assessed according to Common Terminology Criteria for Adverse Events (CTCAE version 4.03). Secondary endpoints include radiological response according to Response Evaluation Criteria in Solid Tumor (version 1.1) and pharmacokinetic analyses. This phase I study can provide the scientific basis to maximize the optimal dose of cisplatin, doxorubicin and oxaliplatin applied as PIPAC.

Keywords: cisplatin; doxorubicin; oxaliplatin; dose escalation; phase I; PIPAC; peritoneal carcinomatosis (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
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