This phase III trial compares whether granisetron, ondansetron, or palonosetron can influence harm to the kidneys, whether cisplatin levels in the body can influence the risk of harm to the kidneys, and whether genetic make-up can increase or decrease the likelihood of kidney injury due to cisplatin therapy. Anti-nausea drugs, such as granisetron, ondansetron, or palonosetron, belong to a class of medications known as 5-hydroxytryptamine antagonists or 5-HT3As and may prevent nausea due to cisplatin treatment. This study may help researchers learn more about the processes that increase the risk of kidney damage from cisplatin therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03817970.
PRIMARY OBJECTIVES:
I. Assess the effects of 5-HT3 antagonist antiemetic drugs on cisplatin secretion and kidney injury.
II. Evaluate cisplatin pharmacokinetics as a biomarker for the detection of nephrotoxicity in patients with cancer.
SECONDARY OBJECTIVE:
I. Identify patients “at risk” for nephrotoxicity based upon genetic polymorphisms in key metabolic and transport pathways for cisplatin disposition.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP A: Within 1-2 hours before cisplatin infusion, patients receive granisetron hydrochloride (granisetron) orally (PO) or intravenously (IV) on day 1.
GROUP B: Within 1-2 hours before cisplatin infusion, patients receive ondansetron PO or IV on day 1.
GROUP C: Within 1-2 hours before cisplatin infusion, patients receive palonosetron hydrochloride (palonosetron) IV on day 1. Patients may also receive granisetron PO and ondansetron PO.
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorMelanie Joy
