Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol
- Conditions
- Malignant Solid Neoplasm
- Interventions
- Registration Number
- NCT03997370
- Lead Sponsor
- NRG Oncology
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 350
-
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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (iohexol, standard care carboplatin, blood samples) Biospecimen Collection 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. Treatment (iohexol, standard care carboplatin, blood samples) Iohexol 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. Treatment (iohexol, standard care carboplatin, blood samples) Carboplatin 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.
- Primary Outcome Measures
Name Time Method Accuracy of achieving the targeted carboplatin area under the curve (AUC) Up to 4 weeks 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.
Precision of the formula for eGFR currently in existence in patients with cancer Up to 4 weeks 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.
Bias of the formula for estimated glomerular filtration rate (eGFR) currently in existence in patients with cancer Up to 4 weeks 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.
Correlation between carboplatin clearance (CL) and mGFR Up to 4 weeks 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.
Precision of achieving the targeted carboplatin AUC Up to 4 weeks 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.
- Secondary Outcome Measures
Name Time Method Divergence of eGFR from mGFR Up to 4 weeks The bias of eGFR versus mGFR will be modeled as a function of the patient's characteristics.
Success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped Up to 4 weeks Among patients with eGFR \> 125 mL/min, precision and bias will be estimated relative to the target carboplatin AUC.
Ability of markers in addition to creatinine in pre-treatment serum to better estimate kidney function in patients with cancer Up to 4 weeks These markers will include (but are not limited to) cystatin C, beta-2-microglobulin (B2M), and beta-trace-protein (BTP). Will use these markers and patient covariates (e.g. sex, race, weight etc.) as predictors for mGFR in regression efforts.
Relationship between carboplatin exposure and toxicity Up to 4 weeks Will be described by the regression parameters for the estimated relationship between carboplatin AUC and platelet count, neutrophil count, and non-hematologic grade 3 toxicities.
Trial Locations
- Locations (179)
University of Arizona Cancer Center-North Campus
🇺🇸Tucson, Arizona, United States
University of Arizona Cancer Center-Orange Grove Campus
🇺🇸Tucson, Arizona, United States
Banner University Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Mercy Hospital Fort Smith
🇺🇸Fort Smith, Arkansas, United States
CARTI Cancer Center
🇺🇸Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
UC San Diego Health System - Encinitas
🇺🇸Encinitas, California, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
University of California Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
UC San Diego Medical Center - Hillcrest
🇺🇸San Diego, California, United States
UCHealth University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins
🇺🇸Fort Collins, Colorado, United States
UCHealth Greeley Hospital
🇺🇸Greeley, Colorado, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
🇺🇸Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
🇺🇸Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
🇺🇸Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
🇺🇸Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital
🇺🇸Emmett, Idaho, United States
Idaho Urologic Institute-Meridian
🇺🇸Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
🇺🇸Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
🇺🇸Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
🇺🇸Sandpoint, Idaho, United States
OSF Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Saint Mary's Hospital
🇺🇸Centralia, Illinois, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Carle at The Riverfront
🇺🇸Danville, Illinois, United States
Carle Physician Group-Effingham
🇺🇸Effingham, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
🇺🇸Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
🇺🇸Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
🇺🇸Highland Park, Illinois, United States
Northwestern Medicine Lake Forest Hospital
🇺🇸Lake Forest, Illinois, United States
Carle Physician Group-Mattoon/Charleston
🇺🇸Mattoon, Illinois, United States
SSM Health Good Samaritan
🇺🇸Mount Vernon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
🇺🇸New Lenox, Illinois, United States
Carle BroMenn Medical Center
🇺🇸Normal, Illinois, United States
Carle Cancer Institute Normal
🇺🇸Normal, Illinois, United States
University of Chicago Medicine-Orland Park
🇺🇸Orland Park, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
The Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Reid Health
🇺🇸Richmond, Indiana, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
🇺🇸Ankeny, Iowa, United States
Saint Anthony Regional Hospital
🇺🇸Carroll, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
🇺🇸Clive, Iowa, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
🇺🇸Des Moines, Iowa, United States
Broadlawns Medical Center
🇺🇸Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
🇺🇸Des Moines, Iowa, United States
Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Trinity Regional Medical Center
🇺🇸Fort Dodge, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
🇺🇸Waukee, Iowa, United States
Methodist West Hospital
🇺🇸West Des Moines, Iowa, United States
Central Care Cancer Center - Garden City
🇺🇸Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
🇺🇸Great Bend, Kansas, United States
Saint Elizabeth Healthcare Edgewood
🇺🇸Edgewood, Kentucky, United States
Hematology/Oncology Clinic PLLC
🇺🇸Baton Rouge, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸Baltimore, Maryland, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Weisberg Cancer Treatment Center
🇺🇸Farmington Hills, Michigan, United States
Saint Louis Cancer and Breast Institute-Ballwin
🇺🇸Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
🇺🇸Bolivar, Missouri, United States
Cox Cancer Center Branson
🇺🇸Branson, Missouri, United States
Mercy Cancer Center - Cape Girardeau
🇺🇸Cape Girardeau, Missouri, United States
Freeman Health System
🇺🇸Joplin, Missouri, United States
Mercy Hospital Joplin
🇺🇸Joplin, Missouri, United States
Lake Regional Hospital
🇺🇸Osage Beach, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
🇺🇸Rolla, Missouri, United States
Phelps Health Delbert Day Cancer Institute
🇺🇸Rolla, Missouri, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital South
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
Mercy Hospital Washington
🇺🇸Washington, Missouri, United States
Community Hospital of Anaconda
🇺🇸Anaconda, Montana, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Bozeman Health Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Benefis Sletten Cancer Institute
🇺🇸Great Falls, Montana, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Hi-Line Sletten Cancer Center
🇺🇸Havre, Montana, United States
Logan Health Medical Center
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge
🇺🇸Basking Ridge, New Jersey, United States
Jefferson Cherry Hill Hospital
🇺🇸Cherry Hill, New Jersey, United States
Memorial Sloan Kettering Monmouth
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
🇺🇸Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Sidney Kimmel Cancer Center Washington Township
🇺🇸Sewell, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
🇺🇸Somerville, New Jersey, United States
Montefiore Medical Center-Einstein Campus
🇺🇸Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
🇺🇸Bronx, New York, United States
Montefiore Medical Center - Moses Campus
🇺🇸Bronx, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Memorial Sloan Kettering Commack
🇺🇸Commack, New York, United States
The Cancer Institute at Saint Francis Hospital
🇺🇸East Hills, New York, United States
Arnot Ogden Medical Center/Falck Cancer Center
🇺🇸Elmira, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Highland Hospital
🇺🇸Rochester, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Blanchard Valley Hospital
🇺🇸Findlay, Ohio, United States
Memorial Sloan Kettering Nassau
🇺🇸Uniondale, New York, United States
Good Samaritan University Hospital
🇺🇸West Islip, New York, United States
Indu and Raj Soin Medical Center
🇺🇸Beavercreek, Ohio, United States
Saint Elizabeth Boardman Hospital
🇺🇸Boardman, Ohio, United States
Dayton Physicians LLC-Miami Valley South
🇺🇸Centerville, Ohio, United States
Miami Valley Hospital South
🇺🇸Centerville, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Kenwood
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Dayton Physician LLC - Englewood
🇺🇸Dayton, Ohio, United States
Miami Valley Hospital North
🇺🇸Dayton, Ohio, United States
Armes Family Cancer Center
🇺🇸Findlay, Ohio, United States
Orion Cancer Care
🇺🇸Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Dayton Physicians LLC-Atrium
🇺🇸Franklin, Ohio, United States
Dayton Physicians LLC-Wayne
🇺🇸Greenville, Ohio, United States
Miami Valley Cancer Care and Infusion
🇺🇸Greenville, Ohio, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
Greater Dayton Cancer Center
🇺🇸Kettering, Ohio, United States
First Dayton Cancer Care
🇺🇸Kettering, Ohio, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Hillcrest Hospital Cancer Center
🇺🇸Mayfield Heights, Ohio, United States
Springfield Regional Cancer Center
🇺🇸Springfield, Ohio, United States
Springfield Regional Medical Center
🇺🇸Springfield, Ohio, United States
Dayton Physicians LLC - Troy
🇺🇸Troy, Ohio, United States
Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Saint Joseph Warren Hospital
🇺🇸Warren, Ohio, United States
University of Cincinnati Cancer Center-West Chester
🇺🇸West Chester, Ohio, United States
Saint Elizabeth Youngstown Hospital
🇺🇸Youngstown, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Saint Alphonsus Cancer Care Center-Baker City
🇺🇸Baker City, Oregon, United States
Saint Alphonsus Cancer Care Center-Ontario
🇺🇸Ontario, Oregon, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
🇺🇸Pittsburgh, Pennsylvania, United States
Asplundh Cancer Pavilion
🇺🇸Willow Grove, Pennsylvania, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
Saint Joseph's/Candler - Bluffton Campus
🇺🇸Bluffton, South Carolina, United States
Vanderbilt-Ingram Cancer Center at Franklin
🇺🇸Franklin, Tennessee, United States
Vanderbilt-Ingram Cancer Center Cool Springs
🇺🇸Franklin, Tennessee, United States
Vanderbilt Breast Center at One Hundred Oaks
🇺🇸Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Utah Sugarhouse Health Center
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah
🇺🇸Salt Lake City, Utah, United States
VCU Massey Cancer Center at Stony Point
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Monongalia Hospital
🇺🇸Morgantown, West Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Billings Clinic-Cody
🇺🇸Cody, Wyoming, United States
Welch Cancer Center
🇺🇸Sheridan, Wyoming, United States
Cancer Center-Metro Medical Center Bayamon
🇵🇷Bayamon, Puerto Rico
Puerto Rico Hematology Oncology Group
🇵🇷Bayamon, Puerto Rico
HIMA San Pablo Oncologic Hospital
🇵🇷Caguas, Puerto Rico
Doctors Cancer Center
🇵🇷Manati, Puerto Rico
Instituto Oncologia Moderna Ponce
🇵🇷Ponce, Puerto Rico
San Juan Community Oncology Group
🇵🇷San Juan, Puerto Rico
Primary Care Physician Group
🇵🇷San Juan, Puerto Rico
Centro Comprensivo de Cancer de UPR
🇵🇷San Juan, Puerto Rico
PROncology
🇵🇷San Juan, Puerto Rico
San Juan City Hospital
🇵🇷San Juan, Puerto Rico