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

Purpose

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.

Condition

  • Malignant Solid Neoplasm

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts 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)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
Contact:
Site Public Contact
520-694-8900

Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373

CARTI Cancer Center
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-906-4199
Research@CARTI.com

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

UC San Diego Moores Cancer Center
La Jolla, California 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

UCHealth University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

Poudre Valley Hospital
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150

Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

UCHealth Greeley Hospital
Greeley, Colorado 80631
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Medical Center of the Rockies
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083

Sibley Memorial Hospital
Washington, District of Columbia 20016
Contact:
Site Public Contact
202-243-2373
jquiver1@jhmi.edu

Emory University Hospital Midtown
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Walter Knox Memorial Hospital
Emmett, Idaho 83617
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Cancer Clinic
Sandpoint, Idaho 83864
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Anthony's Health
Alton, Illinois 62002
Contact:
Site Public Contact
618-463-5623

Saint Mary's Hospital
Centralia, Illinois 62801
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

Carle at The Riverfront
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109

NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109

NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
Contact:
Site Public Contact
618-242-4600

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

The Carle Foundation Hospital
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Reid Health
Richmond, Indiana 47374
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Saint Anthony Regional Hospital
Carroll, Iowa 51401
Contact:
Site Public Contact
515-689-7658
sbenson@iora.org

Iowa Methodist Medical Center
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727

Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305

Broadlawns Medical Center
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-282-2200

Iowa Lutheran Hospital
Des Moines, Iowa 50316
Contact:
Site Public Contact
515-241-8704

Trinity Regional Medical Center
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-574-8302

Methodist West Hospital
West Des Moines, Iowa 50266-7700
Contact:
Site Public Contact
515-343-1000

Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
Contact:
Site Public Contact
410-955-8804
jhcccro@jhmi.edu

Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Contact:
Site Public Contact
301-319-2100

Baystate Medical Center
Springfield, Massachusetts 01199
Contact:
Site Public Contact
413-794-3565
tamara.wrenn@baystatehealth.org

Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Contact:
Site Public Contact
314-251-7058

Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Cox Cancer Center Branson
Branson, Missouri 65616
Contact:
Site Public Contact
417-269-4520

Freeman Health System
Joplin, Missouri 64804
Contact:
Site Public Contact
417-347-4030
LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Joplin, Missouri 64804
Contact:
Site Public Contact
417-556-3074
esmeralda.carrillo@mercy.net

Lake Regional Hospital
Osage Beach, Missouri 65065
Contact:
Site Public Contact
573-302-2768
clinicaltrials@lakeregional.com

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379

Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Contact:
Site Public Contact
816-271-7937
linda.schumacher@mymlc.com

Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri 63109
Contact:
Site Public Contact
314-353-1870

Mercy Hospital South
Saint Louis, Missouri 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520

Mercy Hospital Washington
Washington, Missouri 63090
Contact:
Site Public Contact
636-390-1600

Community Hospital of Anaconda
Anaconda, Montana 59711
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Billings Clinic Cancer Center
Billings, Montana 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Bozeman Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Great Falls Clinic
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kalispell Regional Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Hospital
Missoula, Montana 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
Contact:
Site Public Contact
702-693-6870
jamador@wccenter.com

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356

Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Contact:
Site Public Contact
908-685-2481
Siby.Varughese@rwjbh.org

Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

Memorial Sloan Kettering Commack
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592

Cancer Institute at Saint Francis Hospital
East Hills, New York 11548
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Memorial Sloan Kettering Westchester
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Site Public Contact
212-639-7592

Highland Hospital
Rochester, New York 14620
Contact:
Site Public Contact
585-341-8113

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592

Good Samaritan University Hospital
West Islip, New York 11795
Contact:
Site Public Contact
516-326-7514

Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Saint Elizabeth Boardman Hospital
Boardman, Ohio 44512
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Armes Family Cancer Center
Findlay, Ohio 45840
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Findlay, Ohio 45840
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Orion Cancer Care
Findlay, Ohio 45840
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Wayne Hospital
Greenville, Ohio 45331
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Greater Dayton Cancer Center
Kettering, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Kettering Medical Center
Kettering, Ohio 45429
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC - Troy
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Saint Joseph Warren Hospital
Warren, Ohio 44484
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402

Saint Alphonsus Medical Center-Baker City
Baker City, Oregon 97814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073

Women and Infants Hospital
Providence, Rhode Island 02905
Contact:
Site Public Contact
401-274-1122

Vanderbilt-Ingram Cancer Center at Franklin
Franklin, Tennessee 37067
Contact:
Site Public Contact
800-811-8480

Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee 37067
Contact:
Site Public Contact
800-811-8480

Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204
Contact:
Site Public Contact
800-811-8480

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480

University of Utah Sugarhouse Health Center
Salt Lake City, Utah 84106
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666

Billings Clinic-Cody
Cody, Wyoming 82414
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Welch Cancer Center
Sheridan, Wyoming 82801
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Cancer Center-Metro Medical Center Bayamon
Bayamon, Puerto Rico 00959-5060
Contact:
Site Public Contact
787-395-7085

Doctors Cancer Center
Manati, Puerto Rico 00674
Contact:
Site Public Contact
787-621-4397

San Juan Community Oncology Group
San Juan, Puerto Rico 00917
Contact:
Site Public Contact
787-274-3387

Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico 00927
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

PROncology
San Juan, Puerto Rico 00927
Contact:
Site Public Contact
787-919-7919
info@PRoncology.com

San Juan City Hospital
San Juan, Puerto Rico 00936
Contact:
Site Public Contact
787-763-1296

More Details

NCT ID
NCT03997370
Status
Recruiting
Sponsor
NRG Oncology

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.