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:
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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 Health System - Encinitas
Encinitas, California 92024
Contact:
Site Public Contact
760-536-7700

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

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

UC San Diego Medical Center - Hillcrest
San Diego, California 92103
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rhabbaba@health.ucsd.edu

UCHealth University of Colorado Hospital
Aurora, Colorado 80045
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720-848-0650

Poudre Valley Hospital
Fort Collins, Colorado 80524
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970-297-6150

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

UCHealth Greeley Hospital
Greeley, Colorado 80631
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412-339-5294
Roster@nrgoncology.org

Medical Center of the Rockies
Loveland, Colorado 80538
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970-203-7083

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

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

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

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

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

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

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

Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
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Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
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406-969-6060
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Saint Anthony's Health
Alton, Illinois 62002
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618-463-5623

Saint Mary's Hospital
Centralia, Illinois 62801
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Northwestern University
Chicago, Illinois 60611
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312-695-1301
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Carle at The Riverfront
Danville, Illinois 61832
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800-446-5532
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Carle Physician Group-Effingham
Effingham, Illinois 62401
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800-446-5532
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NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
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847-570-2109

NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
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NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
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Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
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800-446-5532
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Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
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Carle Cancer Center
Urbana, Illinois 61801
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800-446-5532
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The Carle Foundation Hospital
Urbana, Illinois 61801
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Reid Health
Richmond, Indiana 47374
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Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
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Saint Anthony Regional Hospital
Carroll, Iowa 51401
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515-689-7658
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Iowa Methodist Medical Center
Des Moines, Iowa 50309
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515-241-6727

Mission Cancer and Blood - Des Moines
Des Moines, Iowa 50309
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Broadlawns Medical Center
Des Moines, Iowa 50314
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Iowa Lutheran Hospital
Des Moines, Iowa 50316
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Trinity Regional Medical Center
Fort Dodge, Iowa 50501
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Methodist West Hospital
West Des Moines, Iowa 50266-7700
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515-343-1000

Central Care Cancer Center - Garden City
Garden City, Kansas 67846
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913-948-5588
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Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
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Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
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410-955-8804
jhcccro@jhmi.edu

Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
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301-319-2100

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

Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
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314-251-7058

Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
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913-948-5588
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Cox Cancer Center Branson
Branson, Missouri 65616
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417-269-4520

Freeman Health System
Joplin, Missouri 64804
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417-347-4030
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Mercy Hospital Joplin
Joplin, Missouri 64804
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417-556-3074
esmeralda.carrillo@mercy.net

Lake Regional Hospital
Osage Beach, Missouri 65065
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573-302-2768
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Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
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573-458-7504
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Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
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573-458-6379

Heartland Regional Medical Center
Saint Joseph, Missouri 64506
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816-271-7937
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Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri 63109
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314-353-1870

Mercy Hospital South
Saint Louis, Missouri 63128
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314-525-6042
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Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
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314-251-7066

Mercy Hospital Springfield
Springfield, Missouri 65804
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417-269-4520

CoxHealth South Hospital
Springfield, Missouri 65807
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417-269-4520

Mercy Hospital Washington
Washington, Missouri 63090
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636-390-1600

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

Billings Clinic Cancer Center
Billings, Montana 59101
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800-996-2663
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Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
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406-969-6060
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Benefis Sletten Cancer Institute
Great Falls, Montana 59405
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Great Falls Clinic
Great Falls, Montana 59405
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406-969-6060
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Kalispell Regional Medical Center
Kalispell, Montana 59901
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406-969-6060
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Community Medical Center
Missoula, Montana 59804
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406-969-6060
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Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
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702-693-6870
jamador@wccenter.com

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
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212-639-7592

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
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212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
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212-639-7592

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
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732-235-7356

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

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

Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
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718-379-6866
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Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
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718-379-6866
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Montefiore Medical Center - Moses Campus
Bronx, New York 10467
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718-379-6866
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Roswell Park Cancer Institute
Buffalo, New York 14263
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800-767-9355
askroswell@roswellpark.org

Memorial Sloan Kettering Commack
Commack, New York 11725
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212-639-7592

The Cancer Institute at Saint Francis Hospital
East Hills, New York 11548
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516-325-7514
Stephanie.Solito@chsli.org

Memorial Sloan Kettering Westchester
Harrison, New York 10604
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212-639-7592

Memorial Sloan Kettering Cancer Center
New York, New York 10065
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212-639-7592

Highland Hospital
Rochester, New York 14620
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585-341-8113

University of Rochester
Rochester, New York 14642
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585-275-5830

State University of New York Upstate Medical University
Syracuse, New York 13210
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315-464-5476

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
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212-639-7592

Good Samaritan University Hospital
West Islip, New York 11795
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516-326-7514

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

Saint Elizabeth Boardman Hospital
Boardman, Ohio 44512
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937-528-2900
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Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
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937-528-2900
clinical.trials@daytonncorp.org

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

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

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

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

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

Dayton Physician LLC - Englewood
Dayton, Ohio 45415
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937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital North
Dayton, Ohio 45415
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937-528-2900
clinical.trials@daytonncorp.org

Armes Family Cancer Center
Findlay, Ohio 45840
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937-528-2900
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Blanchard Valley Hospital
Findlay, Ohio 45840
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937-528-2900
clinical.trials@daytonncorp.org

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

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
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937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
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937-528-2900
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Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
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937-528-2900
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Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
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937-569-7515

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

Greater Dayton Cancer Center
Kettering, Ohio 45409
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937-528-2900
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Kettering Medical Center
Kettering, Ohio 45429
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937-528-2900
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Dayton Physicians LLC - Troy
Troy, Ohio 45373
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937-528-2900
clinical.trials@daytonncorp.org

Upper Valley Medical Center
Troy, Ohio 45373
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937-528-2900
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Saint Joseph Warren Hospital
Warren, Ohio 44484
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937-528-2900
clinical.trials@daytonncorp.org

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

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

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

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
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405-752-3402

Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon 97814
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406-969-6060
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Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
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406-969-6060
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
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215-600-9151
ONCTrialNow@jefferson.edu

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
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412-647-8073

Women and Infants Hospital
Providence, Rhode Island 02905
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401-274-1122

Vanderbilt-Ingram Cancer Center at Franklin
Franklin, Tennessee 37067
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800-811-8480

Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee 37067
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800-811-8480

Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204
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800-811-8480

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
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800-811-8480

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

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

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
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414-805-3666

Billings Clinic-Cody
Cody, Wyoming 82414
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800-996-2663
research@billingsclinic.org

Welch Cancer Center
Sheridan, Wyoming 82801
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406-969-6060
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Cancer Center-Metro Medical Center Bayamon
Bayamon, Puerto Rico 00959-5060
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787-395-7085

Puerto Rico Hematology Oncology Group
Bayamon, Puerto Rico 00961
Contact:
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787-780-2865

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
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Site Public Contact
787-919-7919
info@PRoncology.com

San Juan City Hospital
San Juan, Puerto Rico 00936
Contact:
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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.