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
3 other identifiers
interventional
318
2 countries
189
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2020
Longer than P75 for phase_1
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedStudy Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 6, 2028
March 27, 2026
March 1, 2026
7.1 years
June 24, 2019
March 23, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (4)
Divergence of eGFR from mGFR
Up to 4 weeks
Success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped
Up to 4 weeks
Relationship between carboplatin exposure and toxicity
Up to 4 weeks
Ability of markers in addition to creatinine in pre-treatment serum to better estimate kidney function in patients with cancer
Up to 4 weeks
Study Arms (1)
Treatment (iohexol, standard care carboplatin, blood samples)
EXPERIMENTALPatients 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.
Interventions
Undergo collection of blood samples
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (189)
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
UC San Diego Health System - Encinitas
Encinitas, California, 92024, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864, United States
OSF Saint Anthony's Health Center
Alton, Illinois, 62002, United States
Saint Mary's Hospital
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Carle BroMenn Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Reid Health
Richmond, Indiana, 47374, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530, United States
Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762, United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017, United States
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, 70809, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Lake Regional Hospital
Osage Beach, Missouri, 65065, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Mercy Hospital Washington
Washington, Missouri, 63090, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Hi-Line Sletten Cancer Center
Havre, Montana, 59501, United States
Benefis Helena Specialty Center
Helena, Montana, 59601, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59804, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Clara Maass Medical Center
Belleville, New Jersey, 07109, United States
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002, United States
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
Elizabeth, New Jersey, 07207, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
The Cancer Institute at Saint Francis Hospital
East Hills, New York, 11548, United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Highland Hospital
Rochester, New York, 14620, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Good Samaritan University Hospital
West Islip, New York, 11795, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
First Dayton Cancer Care
Kettering, Ohio, 45420, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910, United States
Vanderbilt-Ingram Cancer Center at Franklin
Franklin, Tennessee, 37067, United States
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, 37067, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Monongalia Hospital
Morgantown, West Virginia, 26505, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Cancer Center-Metro Medical Center Bayamon
Bayamón, 00959-5060, Puerto Rico
Puerto Rico Hematology Oncology Group
Bayamón, 00961, Puerto Rico
HIMA San Pablo Oncologic Hospital
Caguas, 00726, Puerto Rico
Doctors Cancer Center
Manatí, 00674, Puerto Rico
Instituto Oncologia Moderna Ponce
Ponce, 00716, Puerto Rico
San Juan Community Oncology Group
San Juan, 00917, Puerto Rico
Primary Care Physician Group
San Juan, 00920, Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, 00927, Puerto Rico
PROncology
San Juan, 00927, Puerto Rico
San Juan City Hospital
San Juan, 00936, Puerto Rico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah E Taylor
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2019
First Posted
June 25, 2019
Study Start
January 15, 2020
Primary Completion (Estimated)
February 6, 2027
Study Completion (Estimated)
February 6, 2028
Last Updated
March 27, 2026
Record last verified: 2026-03