Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol (NCT03997370) — Israel Trial Details

Condition(s) studied

Malignant Solid Neoplasm

Investigational drug(s) / intervention(s)

Biospecimen CollectionCarboplatin →Iohexol →

Biospecimen Collection: Undergo collection of blood samples

Carboplatin: Given IV

Iohexol: Given IV

Study summary

This trial studies how well iohexol works in helping doctors calculate the dose of carboplatin given to patients with cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Understanding how to best calculate the dose of carboplatin given to patients with cancer may help doctors learn how to improve the use of carboplatin in the future.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: * Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up * For men who are sexually active, the need for use of medically acceptable contraception will be dictated by the primary treatment plan/protocol * Study accrual was closed to women on 08/18/2021 and accrual is now only open to males in order to meet accrual goals and study objectives. (11-AUG-2021) * Male sex * Any patients who will receive treatment with intravenous carboplatin (any AUC, any cycle) on a National Cancer Institute (NCI)-sponsored National Clinical Trial Network (NCTN)-, Experimental Therapeutics Clinical Trials Network (ETCTN)-, trial, local trial, or through standard of care * Age \>= 18 * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Exclusion Criteria: * Treated at an institute where creatinine is not measured with an IDMS calibrated assay * History of allergic reactions to computed tomography (CT) contrast, iodine or shellfish, or history of anaphylactic reaction to any food item * Recent (last 6 months) episode of acute kidney injury, have sickle cell disease, or have current indwelling nephrostomy tubes * Edema beyond trace edema, because this will impact iohexol equilibration and distribution * Ascites (including pleural effusion) beyond trace ascites, because this will impact iohexol equilibration and distribution * Whole- or part-limb amputees, because this will impact iohexol equilibration and distribution * Inability to maintain a constant dose and schedule of anti-inflammatory agents, diuretics, angiotensin II receptor blockers (ARB) and angiotensin converting enzyme inhibitors (ACEi) for one week prior to study visit, as this impacts renal function. If the patient is on a nonsteroidal anti-inflammatory drug (NSAID), diuretic, ARB or ACEi, they are eligible as long as these agents are taken on a set schedule for 7 or more days prior to study (and not on an "as needed" basis as that can cause fluctuations in renal function) * Inadequate venous access to obtain pharmacokinetic (PK) specimens * Multinodular goiter, Graves' disease or autoimmune thyroiditis, per iohexol package insert (hypothyroidism is allowed)

Primary outcome measure(s)

Accuracy of achieving the targeted carboplatin area under the curve (AUC) — Up to 4 weeks
Will be quantified by the median percentage error (PE), root-mean-squared error (RMSE), interquartile range (IQR) of the residuals, and median absolute percentage error (APE). In addition, the percentage of patients for which the observed carboplatin AUC is within 17% of target will be calculated. The actual AUC will be quantified using atomic absorption spectrophotometry.
Precision of achieving the targeted carboplatin AUC — Up to 4 weeks
Will be quantified by the median PE, RMSE, IQR of the residuals, and median APE. In addition, the percentage of patients for which the observed carboplatin AUC is within 17% of target will be calculated. The actual AUC will be quantified using atomic absorption spectrophotometry.
Bias of the formula for estimated glomerular filtration rate (eGFR) currently in existence in patients with cancer — Up to 4 weeks
Will be quantified by the median PE, RMSE, IQR of the residuals, and median APE will be used to assess the accuracy of each model's eGFR values for predicting measured (m)GFR. In addition, will calculate the percentage of patients for which eGFR is within 30%, 20%, and 10% of mGFR.
Precision of the formula for eGFR currently in existence in patients with cancer — Up to 4 weeks
Will be quantified by the median PE, RMSE, IQR of the residuals, and median APE will be used to assess the accuracy of each model's eGFR values for predicting mGFR. In addition, will calculate the percentage of patients for which eGFR is within 30%, 20%, and 10% of mGFR.
Correlation between carboplatin clearance (CL) and mGFR — Up to 4 weeks
Assessed by regression analysis. Carboplatin clearance will be derived by Empirical Bayes estimation using the POSTHOC option implemented in NONMEM. Will perform regression on the relationship between CL and mGFR. Initially this will follow a linear relationship analogous to the Calvert formula (CL = A + B\* mGFR), and will test if the observed values for A and B are significantly different from those defined by Calvert as A = 25 mL/min and B = 1 (unitless). Will also perform regression by other means, e.g. after log transformation of the data, and assess if this results in a formula that performs better than the Calvert formula or the initial linear model. In addition, the impact of covariates on this relationship will be explored.

Trial sites (189)

Facility	City	Region
University of Arizona Cancer Center-Orange Grove Campus	Tucson	Arizona
Banner University Medical Center - Tucson	Tucson	Arizona
University of Arizona Cancer Center-North Campus	Tucson	Arizona
Mercy Hospital Fort Smith	Fort Smith	Arkansas
CARTI Cancer Center	Little Rock	Arkansas
University of Arkansas for Medical Sciences	Little Rock	Arkansas
UC San Diego Health System - Encinitas	Encinitas	California
UC San Diego Moores Cancer Center	La Jolla	California
University of California Davis Comprehensive Cancer Center	Sacramento	California
UC San Diego Medical Center - Hillcrest	San Diego	California
UCHealth University of Colorado Hospital	Aurora	Colorado
Poudre Valley Hospital	Fort Collins	Colorado
Cancer Care and Hematology-Fort Collins	Fort Collins	Colorado
UCHealth Greeley Hospital	Greeley	Colorado
Medical Center of the Rockies	Loveland	Colorado
Hartford Hospital	Hartford	Connecticut
The Hospital of Central Connecticut	New Britain	Connecticut
Sibley Memorial Hospital	Washington D.C.	District of Columbia
Emory University Hospital Midtown	Atlanta	Georgia
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia
Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho
Saint Alphonsus Cancer Care Center-Caldwell	Caldwell	Idaho
Kootenai Health - Coeur d'Alene	Coeur d'Alene	Idaho
Walter Knox Memorial Hospital	Emmett	Idaho
Idaho Urologic Institute-Meridian	Meridian	Idaho
Saint Alphonsus Cancer Care Center-Nampa	Nampa	Idaho
Kootenai Clinic Cancer Services - Post Falls	Post Falls	Idaho
Kootenai Clinic Cancer Services - Sandpoint	Sandpoint	Idaho
OSF Saint Anthony's Health Center	Alton	Illinois
Saint Mary's Hospital	Centralia	Illinois
Northwestern University	Chicago	Illinois
University of Chicago Comprehensive Cancer Center	Chicago	Illinois
Carle at The Riverfront	Danville	Illinois
Carle Physician Group-Effingham	Effingham	Illinois
NorthShore University HealthSystem-Evanston Hospital	Evanston	Illinois
NorthShore University HealthSystem-Glenbrook Hospital	Glenview	Illinois
NorthShore University HealthSystem-Highland Park Hospital	Highland Park	Illinois
Northwestern Medicine Lake Forest Hospital	Lake Forest	Illinois
Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois

+ 149 more sites — see the full list on the official registry below.

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