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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
Tucson, Arizona 85704
Contact:
Site Public Contact
520-694-8900
Site Public Contact
520-694-8900
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373
Site Public Contact
800-378-9373
CARTI Cancer Center
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
UC San Diego Health System - Encinitas
Encinitas, California 92024
Encinitas, California 92024
Contact:
Site Public Contact
760-536-7700
Site Public Contact
760-536-7700
UC San Diego Moores Cancer Center
La Jolla, California 92093
La Jolla, California 92093
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089
Site Public Contact
916-734-3089
UC San Diego Medical Center - Hillcrest
San Diego, California 92103
San Diego, California 92103
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
Poudre Valley Hospital
Fort Collins, Colorado 80524
Fort Collins, Colorado 80524
Contact:
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970-297-6150
Site Public Contact
970-297-6150
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Fort Collins, Colorado 80528
UCHealth Greeley Hospital
Greeley, Colorado 80631
Greeley, Colorado 80631
Medical Center of the Rockies
Loveland, Colorado 80538
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083
Site Public Contact
970-203-7083
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Savannah, Georgia 31405
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Boise, Idaho 83706
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Walter Knox Memorial Hospital
Emmett, Idaho 83617
Emmett, Idaho 83617
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Post Falls, Idaho 83854
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
Sandpoint, Idaho 83864
Saint Anthony's Health
Alton, Illinois 62002
Alton, Illinois 62002
Contact:
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618-463-5623
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618-463-5623
Saint Mary's Hospital
Centralia, Illinois 62801
Centralia, Illinois 62801
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Evanston, Illinois 60201
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847-570-2109
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847-570-2109
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Glenview, Illinois 60026
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847-570-2109
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847-570-2109
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Highland Park, Illinois 60035
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847-570-2109
Site Public Contact
847-570-2109
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
Mount Vernon, Illinois 62864
Contact:
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618-242-4600
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618-242-4600
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
The Carle Foundation Hospital
Urbana, Illinois 61801
Urbana, Illinois 61801
Reid Health
Richmond, Indiana 47374
Richmond, Indiana 47374
Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
Ankeny, Iowa 50023
Contact:
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515-282-2921
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515-282-2921
Saint Anthony Regional Hospital
Carroll, Iowa 51401
Carroll, Iowa 51401
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
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515-241-6727
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515-241-6727
Mission Cancer and Blood - Des Moines
Des Moines, Iowa 50309
Des Moines, Iowa 50309
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515-241-3305
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515-241-3305
Broadlawns Medical Center
Des Moines, Iowa 50314
Des Moines, Iowa 50314
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515-282-2200
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515-282-2200
Iowa Lutheran Hospital
Des Moines, Iowa 50316
Des Moines, Iowa 50316
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515-241-8704
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515-241-8704
Trinity Regional Medical Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
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515-574-8302
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515-574-8302
Methodist West Hospital
West Des Moines, Iowa 50266-7700
West Des Moines, Iowa 50266-7700
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515-343-1000
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515-343-1000
Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Garden City, Kansas 67846
Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
Great Bend, Kansas 67530
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Bethesda, Maryland 20889-5600
Contact:
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301-319-2100
Site Public Contact
301-319-2100
Baystate Medical Center
Springfield, Massachusetts 01199
Springfield, Massachusetts 01199
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Ballwin, Missouri 63011
Contact:
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314-251-7058
Site Public Contact
314-251-7058
Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
Bolivar, Missouri 65613
Cox Cancer Center Branson
Branson, Missouri 65616
Branson, Missouri 65616
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Freeman Health System
Joplin, Missouri 64804
Joplin, Missouri 64804
Mercy Hospital Joplin
Joplin, Missouri 64804
Joplin, Missouri 64804
Lake Regional Hospital
Osage Beach, Missouri 65065
Osage Beach, Missouri 65065
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Rolla, Missouri 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Rolla, Missouri 65401
Contact:
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573-458-6379
Site Public Contact
573-458-6379
Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri 63109
Saint Louis, Missouri 63109
Contact:
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314-353-1870
Site Public Contact
314-353-1870
Mercy Hospital South
Saint Louis, Missouri 63128
Saint Louis, Missouri 63128
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Contact:
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314-251-7066
Site Public Contact
314-251-7066
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
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417-269-4520
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417-269-4520
CoxHealth South Hospital
Springfield, Missouri 65807
Springfield, Missouri 65807
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417-269-4520
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417-269-4520
Mercy Hospital Washington
Washington, Missouri 63090
Washington, Missouri 63090
Contact:
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636-390-1600
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636-390-1600
Community Hospital of Anaconda
Anaconda, Montana 59711
Anaconda, Montana 59711
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Bozeman, Montana 59715
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Great Falls Clinic
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell Regional Medical Center
Kalispell, Montana 59901
Kalispell, Montana 59901
Community Medical Center
Missoula, Montana 59804
Missoula, Montana 59804
Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Contact:
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212-639-7592
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212-639-7592
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Middletown, New Jersey 07748
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212-639-7592
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212-639-7592
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Montvale, New Jersey 07645
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212-639-7592
Site Public Contact
212-639-7592
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
Sewell, New Jersey 08080
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Somerville, New Jersey 08876
Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Bronx, New York 10461
Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
Bronx, New York 10461
Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Bronx, New York 10467
Roswell Park Cancer Institute
Buffalo, New York 14263
Buffalo, New York 14263
Memorial Sloan Kettering Commack
Commack, New York 11725
Commack, New York 11725
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Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
The Cancer Institute at Saint Francis Hospital
East Hills, New York 11548
East Hills, New York 11548
Memorial Sloan Kettering Westchester
Harrison, New York 10604
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
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212-639-7592
Site Public Contact
212-639-7592
Highland Hospital
Rochester, New York 14620
Rochester, New York 14620
Contact:
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585-341-8113
Site Public Contact
585-341-8113
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
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585-275-5830
Site Public Contact
585-275-5830
State University of New York Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
Contact:
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315-464-5476
Site Public Contact
315-464-5476
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Uniondale, New York 11553
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212-639-7592
Site Public Contact
212-639-7592
Good Samaritan University Hospital
West Islip, New York 11795
West Islip, New York 11795
Contact:
Site Public Contact
516-326-7514
Site Public Contact
516-326-7514
Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
Beavercreek, Ohio 45431
Saint Elizabeth Boardman Hospital
Boardman, Ohio 44512
Boardman, Ohio 44512
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Centerville, Ohio 45459
Miami Valley Hospital South
Centerville, Ohio 45459
Centerville, Ohio 45459
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
Cincinnati, Ohio 45236
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Miami Valley Hospital
Dayton, Ohio 45409
Dayton, Ohio 45409
Dayton Physician LLC - Englewood
Dayton, Ohio 45415
Dayton, Ohio 45415
Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Armes Family Cancer Center
Findlay, Ohio 45840
Findlay, Ohio 45840
Blanchard Valley Hospital
Findlay, Ohio 45840
Findlay, Ohio 45840
Orion Cancer Care
Findlay, Ohio 45840
Findlay, Ohio 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Franklin, Ohio 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Franklin, Ohio 45005
Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
Greenville, Ohio 45331
Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515
Site Public Contact
937-569-7515
Wayne Hospital
Greenville, Ohio 45331
Greenville, Ohio 45331
Greater Dayton Cancer Center
Kettering, Ohio 45409
Kettering, Ohio 45409
Kettering Medical Center
Kettering, Ohio 45429
Kettering, Ohio 45429
Dayton Physicians LLC - Troy
Troy, Ohio 45373
Troy, Ohio 45373
Upper Valley Medical Center
Troy, Ohio 45373
Troy, Ohio 45373
Saint Joseph Warren Hospital
Warren, Ohio 44484
Warren, Ohio 44484
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
West Chester, Ohio 45069
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
Youngstown, Ohio 44501
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402
Site Public Contact
405-752-3402
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon 97814
Baker City, Oregon 97814
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
Ontario, Oregon 97914
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
Women and Infants Hospital
Providence, Rhode Island 02905
Providence, Rhode Island 02905
Contact:
Site Public Contact
401-274-1122
Site Public Contact
401-274-1122
Vanderbilt-Ingram Cancer Center at Franklin
Franklin, Tennessee 37067
Franklin, Tennessee 37067
Contact:
Site Public Contact
800-811-8480
Site Public Contact
800-811-8480
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee 37067
Franklin, Tennessee 37067
Contact:
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800-811-8480
Site Public Contact
800-811-8480
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204
Nashville, Tennessee 37204
Contact:
Site Public Contact
800-811-8480
Site Public Contact
800-811-8480
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480
Site Public Contact
800-811-8480
University of Utah Sugarhouse Health Center
Salt Lake City, Utah 84106
Salt Lake City, Utah 84106
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666
Site Public Contact
414-805-3666
Billings Clinic-Cody
Cody, Wyoming 82414
Cody, Wyoming 82414
Welch Cancer Center
Sheridan, Wyoming 82801
Sheridan, Wyoming 82801
Cancer Center-Metro Medical Center Bayamon
Bayamon, Puerto Rico 00959-5060
Bayamon, Puerto Rico 00959-5060
Contact:
Site Public Contact
787-395-7085
Site Public Contact
787-395-7085
Puerto Rico Hematology Oncology Group
Bayamon, Puerto Rico 00961
Bayamon, Puerto Rico 00961
Contact:
Site Public Contact
787-780-2865
Site Public Contact
787-780-2865
Doctors Cancer Center
Manati, Puerto Rico 00674
Manati, Puerto Rico 00674
Contact:
Site Public Contact
787-621-4397
Site Public Contact
787-621-4397
San Juan Community Oncology Group
San Juan, Puerto Rico 00917
San Juan, Puerto Rico 00917
Contact:
Site Public Contact
787-274-3387
Site Public Contact
787-274-3387
Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
PROncology
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
San Juan City Hospital
San Juan, Puerto Rico 00936
San Juan, Puerto Rico 00936
Contact:
Site Public Contact
787-763-1296
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.