August 20 2020
NRG-GY022, “Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin” opened to enrollment on November 11, 2019. This study was developed by the Developmental Therapeutics Committee under the GYN committee and it is open to ALL disease sites.
The current dosing standard for carboplatin uses an area under the concentration time curve (AUC) formulation. Carboplatin has an exposure-response relationship with increasing AUC resulting in increased antitumor activity, which plateaus, with further increases in exposure resulting in increased toxicity. The current approach to dosing carboplatin has become an accumulation of assumptions with estimates known to be imprecise or biased. This can lead to under- or overdosing with potentially increased toxicity without enhanced efficacy.
NRG-GY022 uses a dilute formulation of iohexol, an iodinated contrast material standardly used in nephrology, to directly measure glomerular filtration rate (GFR), instead of estimating it, as has been the historical standard. The study involves a once-off, single day of timed PK draws after the patient receives a dose of the iohexol and their scheduled infusion of carboplatin. Any patient receiving carboplatin, on study or as part of standard of care, is potentially eligible to enroll. Standard laboratory data and toxicity data will be collected in order to compare historical estimates of GFR to the measured GFR as well as the relationship between the carboplatin exposure and toxicity
Example day for a patient taking part in this study.
Carboplatin is widely used and so accurate dosing could have a huge impact on cancer patients across disease sites, at the time of primary diagnosis and in the setting of recurrent disease. Please consider enrolling your patients on this important study.
Protocol documents are located on the CTSU webpage. The only protocol requirement to activate is to obtain IRB approval (CIRB). All sites participating on this PK study are eligible for per case reimbursement.