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

Trial Status: Active

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.

Inclusion Criteria

  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • For women of childbearing potential and men who are sexually active, the need for use of medically acceptable contraception will be dictated by the primary treatment plan/protocol
  • 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
  • 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)

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE
Contact: Site Public Contact
University of Arizona Cancer Center-North Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-327-2873
University of Arizona Cancer Center-Orange Grove Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 520-694-8900

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-378-9373
Little Rock
University of Arkansas for Medical Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 501-686-8274

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 720-848-0650
Fort Collins
Cancer Care and Hematology-Fort Collins
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Poudre Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-297-6150
Greeley
UCHealth Greeley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Loveland
Medical Center of the Rockies
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-203-7083

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Emmett
Walter Knox Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Post Falls
Kootenai Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

Illinois

Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: ACTIVE
Contact: Site Public Contact
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Orland Park
University of Chicago Medicine-Orland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222

Indiana

Richmond
Reid Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270

Maryland

Bethesda
Walter Reed National Military Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 301-319-2100

Massachusetts

Springfield
Baystate Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 413-794-3565

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7058
Branson
Cox Cancer Center Branson
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-353-1870
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

Nevada

Las Vegas
Women's Cancer Center of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-693-6870

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-8675
Somerville
Robert Wood Johnson University Hospital Somerset
Status: ACTIVE
Contact: Site Public Contact
Phone: 908-685-2481

New York

Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Elmira
Arnot Ogden Medical Center / Falck Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 607-271-7000
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Rochester
Highland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592

Ohio

Beavercreek
Indu and Raj Soin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Boardman
Saint Elizabeth Boardman Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-775-1350
Centerville
Dayton Physicians LLC-Miami Valley South
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-775-1350
Miami Valley Hospital South
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Cincinnati
Oncology Hematology Care Inc-Kenwood
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
University of Cincinnati / Barrett Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-558-4553
Cleveland
Cleveland Clinic Cancer Center / Fairview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Miami Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Blanchard Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Orion Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Dayton Physicians LLC-Atrium
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Greenville
Dayton Physicians LLC-Wayne
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Wayne Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Kettering
First Dayton Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Greater Dayton Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Kettering Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Springfield
Springfield Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-775-1350
Springfield Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Troy
Dayton Physicians LLC-Upper Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Upper Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Warren
Saint Joseph Warren Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-775-1350
West Chester
University Pointe
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Youngstown
Saint Elizabeth Youngstown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-775-1350

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-8073

Rhode Island

Providence
Women and Infants Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 401-274-1122

Tennessee

Franklin
Vanderbilt-Ingram Cancer Center Cool Springs
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-811-8480
Vanderbilt-Ingram Cancer Center at Franklin
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-811-8480
Nashville
Vanderbilt Breast Center at One Hundred Oaks
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-811-8480
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-811-8480

Wisconsin

Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666

Wyoming

Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

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.

Trial Phase Phase NA

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Sarah E. Taylor

  • Primary ID NRG-GY022
  • Secondary IDs NCI-2019-04008
  • Clinicaltrials.gov ID NCT03997370