Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases
| Autor: | Marco Vaira, M. Robella, Alice Borsano, Alba Ilari Civit, A. Cinquegrana, Paola Berchialla, Michele De Simone |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Cisplatin
Dose escalation Doxorubicin Oxaliplatin Peritoneal carcinomatosis Phase I PIPAC Aerosols Clinical Trials Phase I as Topic Humans Peritoneum Peritoneal Neoplasms medicine.medical_specialty Health Toxicology and Mutagenesis medicine.medical_treatment Urology cisplatin Phase I as Topic doxorubicin Article 03 medical and health sciences 0302 clinical medicine Pharmacokinetics medicine Clinical Trials Chemotherapy business.industry oxaliplatin Public Health Environmental and Occupational Health peritoneal carcinomatosis Common Terminology Criteria for Adverse Events phase I 030220 oncology & carcinogenesis Toxicity dose escalation Medicine 030211 gastroenterology & hepatology business medicine.drug |
| Zdroj: | International Journal of Environmental Research and Public Health International Journal of Environmental Research and Public Health, Vol 18, Iss 5656, p 5656 (2021) Volume 18 Issue 11 |
| ISSN: | 1660-4601 1661-7827 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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