Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol

Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Solid Neoplasm
• Intervention / Treatment: Drug: Carboplatin; Procedure: Biospecimen Collection; Drug: Iohexol

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate the success of targeting a carboplatin area under the curve (AUC) with our current approach to dosing carboplatin.

II. Assess the performance of Cockcroft-Gault (CG), four-variable Modification of Diet in Renal Disease (MDRD-4), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) based on isotope dilution mass spectrometry (IDMS) calibrated serum creatinine in predicting measured glomerular filtration rate (mGFR) in patients with cancer.

III. Define the relationship of mGFR and carboplatin clearance in patients with cancer.

SECONDARY OBJECTIVES:

I. Evaluate the divergence of estimated (e)GFR from mGFR based on patient demographic and other characteristics, thus identifying those most likely to benefit from determination of mGFR over use of eGFR.

II. Determine the success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped.

III. Evaluate the relationship between carboplatin exposure and toxicity. IV. Assess the ability of markers other than creatinine in pre-treatment serum to better estimate kidney function in patients with cancer.

OUTLINE:

Patients receive iohexol intravenously (IV) over 30-60 seconds. Patients then receive standard of care carboplatin IV. Patients also undergo collection of 7-8 blood samples for analysis.

After completion of study, patients are followed up for 3-4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Phase 1

Contacts and Locations

Study Locations

• Puerto Rico
  • Bayamón, Puerto Rico, 00959-5060
    • Cancer Center-Metro Medical Center Bayamon
  • Bayamón, Puerto Rico, 00961
    • Puerto Rico Hematology Oncology Group
  • Caguas, Puerto Rico, 00726
    • HIMA San Pablo Oncologic Hospital
  • Manatí, Puerto Rico, 00674
    • Doctors Cancer Center
  • Ponce, Puerto Rico, 00716
    • Instituto Oncologia Moderna Ponce
  • San Juan, Puerto Rico, 00917
    • San Juan Community Oncology Group
  • San Juan, Puerto Rico, 00927
    • Centro Comprensivo de Cancer de UPR
  • San Juan, Puerto Rico, 00936
    • San Juan City Hospital
  • San Juan, Puerto Rico, 00920
    • Primary Care Physician Group
  • San Juan, Puerto Rico, 00927
    • PROncology
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • University of Arizona Cancer Center-Orange Grove Campus
    • Tucson, Arizona, United States, 85719
      • Banner University Medical Center - Tucson
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center-North Campus
  • Arkansas
    • Fort Smith, Arkansas, United States, 72903
      • Mercy Hospital Fort Smith
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
    • Little Rock, Arkansas, United States, 72205
      • CARTI Cancer Center
  • California
    • Encinitas, California, United States, 92024
      • UC San Diego Health System - Encinitas
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Sacramento, California, United States, 95817
      • University of California Davis Comprehensive Cancer Center
    • San Diego, California, United States, 92103
      • UC San Diego Medical Center - Hillcrest
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth University of Colorado Hospital
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
    • Fort Collins, Colorado, United States, 80528
      • Cancer Care and Hematology-Fort Collins
    • Greeley, Colorado, United States, 80631
      • UCHealth Greeley Hospital
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • New Britain, Connecticut, United States, 06050
      • The Hospital of Central Connecticut
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Sibley Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Idaho
    • Boise, Idaho, United States, 83706
      • Saint Alphonsus Cancer Care Center-Boise
    • Caldwell, Idaho, United States, 83605
      • Saint Alphonsus Cancer Care Center-Caldwell
    • Coeur d'Alene, Idaho, United States, 83814
      • Kootenai Health - Coeur d'Alene
    • Emmett, Idaho, United States, 83617
      • Walter Knox Memorial Hospital
    • Meridian, Idaho, United States, 83642
      • Idaho Urologic Institute-Meridian
    • Nampa, Idaho, United States, 83687
      • Saint Alphonsus Cancer Care Center-Nampa
    • Post Falls, Idaho, United States, 83854
      • Kootenai Clinic Cancer Services - Post Falls
    • Sandpoint, Idaho, United States, 83864
      • Kootenai Clinic Cancer Services - Sandpoint
  • Illinois
    • Alton, Illinois, United States, 62002
      • OSF Saint Anthony's Health Center
    • Centralia, Illinois, United States, 62801
      • Saint Mary's Hospital
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60637
      • University of Chicago Comprehensive Cancer Center
    • Danville, Illinois, United States, 61832
      • Carle at The Riverfront
    • Effingham, Illinois, United States, 62401
      • Carle Physician Group-Effingham
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem-Evanston Hospital
    • Glenview, Illinois, United States, 60026
      • NorthShore University HealthSystem-Glenbrook Hospital
    • Highland Park, Illinois, United States, 60035
      • NorthShore University HealthSystem-Highland Park Hospital
    • Lake Forest, Illinois, United States, 60045
      • Northwestern Medicine Lake Forest Hospital
    • Mattoon, Illinois, United States, 61938
      • Carle Physician Group-Mattoon/Charleston
    • Mount Vernon, Illinois, United States, 62864
      • SSM Health Good Samaritan
    • New Lenox, Illinois, United States, 60451
      • UC Comprehensive Cancer Center at Silver Cross
    • Normal, Illinois, United States, 61761
      • Carle Cancer Institute Normal
    • Normal, Illinois, United States, 61761
      • Carle BroMenn Medical Center
    • Orland Park, Illinois, United States, 60462
      • University of Chicago Medicine-Orland Park
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
    • Urbana, Illinois, United States, 61801
      • The Carle Foundation Hospital
  • Indiana
    • Richmond, Indiana, United States, 47374
      • Reid Health
  • Iowa
    • Ankeny, Iowa, United States, 50023
      • UI Health Care Mission Cancer and Blood - Ankeny Clinic
    • Carroll, Iowa, United States, 51401
      • Saint Anthony Regional Hospital
    • Clive, Iowa, United States, 50325
      • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
    • Des Moines, Iowa, United States, 50309
      • Iowa Methodist Medical Center
    • Des Moines, Iowa, United States, 50314
      • Broadlawns Medical Center
    • Des Moines, Iowa, United States, 50316
      • Iowa Lutheran Hospital
    • Des Moines, Iowa, United States, 50309
      • UI Health Care Mission Cancer and Blood - Des Moines Clinic
    • Des Moines, Iowa, United States, 50314
      • UI Health Care Mission Cancer and Blood - Laurel Clinic
    • Fort Dodge, Iowa, United States, 50501
      • UI Healthcare Mission Cancer and Blood - Fort Dodge
    • Waukee, Iowa, United States, 50263
      • UI Health Care Mission Cancer and Blood - Waukee Clinic
    • West Des Moines, Iowa, United States, 50266-7700
      • Methodist West Hospital
  • Kansas
    • Garden City, Kansas, United States, 67846
      • Central Care Cancer Center - Garden City
    • Great Bend, Kansas, United States, 67530
      • Central Care Cancer Center - Great Bend
    • Pittsburg, Kansas, United States, 66762
      • Mercy Hospital Pittsburg
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Saint Elizabeth Healthcare Edgewood
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Hematology/Oncology Clinic PLLC
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Bethesda, Maryland, United States, 20889-5600
      • Walter Reed National Military Medical Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University/Karmanos Cancer Institute
    • Farmington Hills, Michigan, United States, 48334
      • Weisberg Cancer Treatment Center
  • Missouri
    • Ballwin, Missouri, United States, 63011
      • Mercy Oncology and Hematology - Clayton-Clarkson
    • Bolivar, Missouri, United States, 65613
      • Central Care Cancer Center - Bolivar
    • Branson, Missouri, United States, 65616
      • Cox Cancer Center Branson
    • Cape Girardeau, Missouri, United States, 63703
      • Mercy Cancer Center - Cape Girardeau
    • Joplin, Missouri, United States, 64804
      • Freeman Health System
    • Joplin, Missouri, United States, 64804
      • Mercy Hospital Joplin
    • Osage Beach, Missouri, United States, 65065
      • Lake Regional Hospital
    • Rolla, Missouri, United States, 65401
      • Mercy Clinic-Rolla-Cancer and Hematology
    • Rolla, Missouri, United States, 65401
      • Phelps Health Delbert Day Cancer Institute
    • Saint Joseph, Missouri, United States, 64506
      • Heartland Regional Medical Center
    • Springfield, Missouri, United States, 65807
      • CoxHealth South Hospital
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
    • St Louis, Missouri, United States, 63109
      • Mercy Infusion Center - Chippewa
    • St Louis, Missouri, United States, 63141
      • Mercy Hospital Saint Louis
    • St Louis, Missouri, United States, 63128
      • Mercy Hospital South
    • Washington, Missouri, United States, 63090
      • Mercy Hospital Washington
  • Montana
    • Anaconda, Montana, United States, 59711
      • Community Hospital of Anaconda
    • Billings, Montana, United States, 59101
      • Billings Clinic Cancer Center
    • Bozeman, Montana, United States, 59715
      • Bozeman Health Deaconess Hospital
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic
    • Great Falls, Montana, United States, 59405
      • Benefis Sletten Cancer Institute
    • Havre, Montana, United States, 59501
      • Hi-Line Sletten Cancer Center
    • Helena, Montana, United States, 59601
      • Benefis Helena Specialty Center
    • Kalispell, Montana, United States, 59901
      • Logan Health Medical Center
    • Missoula, Montana, United States, 59804
      • Community Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Women's Cancer Center of Nevada
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
    • Belleville, New Jersey, United States, 07109
      • Clara Maass Medical Center
    • Cherry Hill, New Jersey, United States, 08002
      • Jefferson Cherry Hill Hospital
    • Elizabeth, New Jersey, United States, 07207
      • Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center
    • Long Branch, New Jersey, United States, 07740
      • Monmouth Medical Center
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
    • Newark, New Jersey, United States, 07101
      • Rutgers New Jersey Medical School
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
    • Sewell, New Jersey, United States, 08080
      • Sidney Kimmel Cancer Center Washington Township
    • Somerville, New Jersey, United States, 08876
      • Robert Wood Johnson University Hospital Somerset
    • Toms River, New Jersey, United States, 08755
      • Community Medical Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • East Hills, New York, United States, 11548
      • The Cancer Institute at Saint Francis Hospital
    • Elmira, New York, United States, 14905
      • Arnot Ogden Medical Center/Falck Cancer Center
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14620
      • Highland Hospital
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical University
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center-Einstein Campus
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center - Moses Campus
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center-Weiler Hospital
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau
    • West Islip, New York, United States, 11795
      • Good Samaritan University Hospital
  • Ohio
    • Beavercreek, Ohio, United States, 45431
      • Indu and Raj Soin Medical Center
    • Boardman, Ohio, United States, 44512
      • Saint Elizabeth Boardman Hospital
    • Centerville, Ohio, United States, 45459
      • Miami Valley Hospital South
    • Centerville, Ohio, United States, 45459
      • Dayton Physicians LLC-Miami Valley South
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Cancer Center-UC Medical Center
    • Cincinnati, Ohio, United States, 45236
      • Oncology Hematology Care Inc-Kenwood
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Cancer Center/Fairview Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
    • Dayton, Ohio, United States, 45409
      • Miami Valley Hospital
    • Dayton, Ohio, United States, 45415
      • Miami Valley Hospital North
    • Dayton, Ohio, United States, 45415
      • Dayton Physician LLC - Englewood
    • Findlay, Ohio, United States, 45840
      • Blanchard Valley Hospital
    • Findlay, Ohio, United States, 45840
      • Armes Family Cancer Center
    • Findlay, Ohio, United States, 45840
      • Orion Cancer Care
    • Franklin, Ohio, United States, 45005-1066
      • Atrium Medical Center-Middletown Regional Hospital
    • Franklin, Ohio, United States, 45005
      • Dayton Physicians LLC-Atrium
    • Greenville, Ohio, United States, 45331
      • Wayne Hospital
    • Greenville, Ohio, United States, 45331
      • Dayton Physicians LLC-Wayne
    • Greenville, Ohio, United States, 45331
      • Miami Valley Cancer Care and Infusion
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
    • Kettering, Ohio, United States, 45409
      • Greater Dayton Cancer Center
    • Kettering, Ohio, United States, 45420
      • First Dayton Cancer Care
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Hospital Cancer Center
    • Springfield, Ohio, United States, 45504
      • Springfield Regional Cancer Center
    • Springfield, Ohio, United States, 45504
      • Springfield Regional Medical Center
    • Troy, Ohio, United States, 45373
      • Upper Valley Medical Center
    • Troy, Ohio, United States, 45373
      • Dayton Physicians LLC - Troy
    • Warren, Ohio, United States, 44484
      • Saint Joseph Warren Hospital
    • West Chester, Ohio, United States, 45069
      • University of Cincinnati Cancer Center-West Chester
    • Youngstown, Ohio, United States, 44501
      • Saint Elizabeth Youngstown Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
    • Oklahoma City, Oklahoma, United States, 73120
      • Mercy Hospital Oklahoma City
  • Oregon
    • Baker City, Oregon, United States, 97814
      • Saint Alphonsus Cancer Care Center-Baker City
    • Ontario, Oregon, United States, 97914
      • Saint Alphonsus Cancer Care Center-Ontario
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Cancer Institute (UPCI)
    • Willow Grove, Pennsylvania, United States, 19090
      • Asplundh Cancer Pavilion
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital
  • South Carolina
    • Bluffton, South Carolina, United States, 29910
      • Saint Joseph's/Candler - Bluffton Campus
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Vanderbilt-Ingram Cancer Center Cool Springs
    • Franklin, Tennessee, United States, 37067
      • Vanderbilt-Ingram Cancer Center at Franklin
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University/Ingram Cancer Center
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt Breast Center at One Hundred Oaks
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute/University of Utah
    • Salt Lake City, Utah, United States, 84106
      • University of Utah Sugarhouse Health Center
  • Virginia
    • Richmond, Virginia, United States, 23235
      • VCU Massey Cancer Center at Stony Point
    • Richmond, Virginia, United States, 23298
      • VCU Massey Comprehensive Cancer Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Monongalia Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
  • Wyoming
    • Cheyenne, Wyoming, United States, 82001
      • Memorial Hospital of Laramie County
    • Cody, Wyoming, United States, 82414
      • Billings Clinic-Cody
    • Sheridan, Wyoming, United States, 82801
      • Welch Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (iohexol, standard care carboplatin, blood samples); Patients receive iohexol IV over 30-60 seconds. Patients then receive standard of care carboplatin IV. Patients also undergo collection of 7-8 blood samples for analysis.

Drug: Carboplatin; Given IV; Other Names: Blastocarb; Carboplat; Carboplatin Hexal; Carboplatino; Carboplatinum; Carbosin; Carbosol; Carbotec; CBDCA; Displata; Ercar; JM-8; Nealorin; Novoplatinum; Paraplatin; Paraplatin AQ; Paraplatine; Platinwas; Ribocarbo; JM8; Procedure: Biospecimen Collection; Undergo collection of blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Iohexol; Given IV; Other Names: Omnipaque

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of achieving the targeted carboplatin area under the curve (AUC)	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.	Up to 4 weeks
Precision of achieving the targeted carboplatin AUC	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.	Up to 4 weeks
Bias of the formula for estimated glomerular filtration rate (eGFR) currently in existence in patients with cancer	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.	Up to 4 weeks
Precision of the formula for eGFR currently in existence in patients with cancer	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.	Up to 4 weeks
Correlation between carboplatin clearance (CL) and mGFR	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.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Divergence of eGFR from mGFR	The bias of eGFR versus mGFR will be modeled as a function of the patient's characteristics.	Up to 4 weeks
Success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped	Among patients with eGFR > 125 mL/min, precision and bias will be estimated relative to the target carboplatin AUC.	Up to 4 weeks
Relationship between carboplatin exposure and toxicity	Will be described by the regression parameters for the estimated relationship between carboplatin AUC and platelet count, neutrophil count, and non-hematologic grade 3 toxicities.	Up to 4 weeks
Ability of markers in addition to creatinine in pre-treatment serum to better estimate kidney function in patients with cancer	These markers will include (but are not limited to) cystatin C, beta-2-microglobulin (B2M), and beta-trace-protein (BTP). Will use these markers and patient covariates (e.g. sex, race, weight etc.) as predictors for mGFR in regression efforts.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: NRG Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sarah E Taylor, NRG Oncology

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Estimated): February 6, 2027
• Study Completion (Estimated): February 6, 2028

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Coordination Complexes; Benzene Derivatives; Acids, Carbocyclic; Benzoates; Triiodobenzoic Acids; Iodobenzoates; Carboplatin; Specimen Handling; Iohexol
• Other Study ID Numbers: NRG-GY022 (Other Identifier: CTEP); U10CA180868 (U.S. NIH Grant/Contract); NCI-2019-04008 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• IPD Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No