Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases
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, cis...
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doaj-fdb2a0fec9ad447dbb84b6d68176cad62021-06-01T01:05:15ZengMDPI AGInternational Journal of Environmental Research and Public Health1661-78271660-46012021-05-01185656565610.3390/ijerph18115656Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal MetastasesManuela Robella0Paola Berchialla1Alice Borsano2Armando Cinquegrana3Alba Ilari Civit4Michele De Simone5Marco Vaira6Unit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, ItalyDepartment of Clinical and Biological Sciences, University of Turin, 10124 Turin, ItalyUnit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, ItalyUnit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, ItalyUnit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, ItalyUnit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, ItalyUnit of Surgical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l’Oncologia—IRCCS, 10060 Candiolo, ItalyPressurized 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.https://www.mdpi.com/1660-4601/18/11/5656cisplatindoxorubicinoxaliplatindose escalationphase IPIPAC |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Manuela Robella Paola Berchialla Alice Borsano Armando Cinquegrana Alba Ilari Civit Michele De Simone Marco Vaira |
spellingShingle |
Manuela Robella Paola Berchialla Alice Borsano Armando Cinquegrana Alba Ilari Civit Michele De Simone Marco Vaira Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases International Journal of Environmental Research and Public Health cisplatin doxorubicin oxaliplatin dose escalation phase I PIPAC |
author_facet |
Manuela Robella Paola Berchialla Alice Borsano Armando Cinquegrana Alba Ilari Civit Michele De Simone Marco Vaira |
author_sort |
Manuela Robella |
title |
Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases |
title_short |
Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases |
title_full |
Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases |
title_fullStr |
Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases |
title_full_unstemmed |
Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases |
title_sort |
study protocol: phase i dose escalation study of oxaliplatin, cisplatin and doxorubicin applied as pipac in patients with peritoneal metastases |
publisher |
MDPI AG |
series |
International Journal of Environmental Research and Public Health |
issn |
1661-7827 1660-4601 |
publishDate |
2021-05-01 |
description |
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. |
topic |
cisplatin doxorubicin oxaliplatin dose escalation phase I PIPAC |
url |
https://www.mdpi.com/1660-4601/18/11/5656 |
work_keys_str_mv |
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