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NCT03997370 Clinical Trial

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

Malignant Solid Neoplasm Clinical Trial

Official title:
Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03997370
Other study ID # NRG-GY022
Secondary ID NCI-2019-04008NR
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 15, 2020
Est. completion date February 6, 2028

Study information
Verified date May 2024
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 350
Est. completion date February 6, 2028
Est. primary completion date February 6, 2027
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples
Drug:
• Carboplatin
Given IV
• Iohexol
Given IV

Locations
Country Name City State
Puerto Rico Cancer Center-Metro Medical Center Bayamon Bayamon
Puerto Rico HIMA San Pablo Oncologic Hospital Caguas
Puerto Rico Doctors Cancer Center Manati
Puerto Rico Instituto Oncologia Moderna Ponce Ponce
Puerto Rico Centro Comprensivo de Cancer de UPR San Juan
Puerto Rico Primary Care Physician Group San Juan
Puerto Rico PROncology San Juan
Puerto Rico San Juan City Hospital San Juan
Puerto Rico San Juan Community Oncology Group San Juan
United States Saint Anthony's Health Alton Illinois
United States Community Hospital of Anaconda Anaconda Montana
United States Mission Cancer and Blood - Ankeny Ankeny Iowa
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States UCHealth University of Colorado Hospital Aurora Colorado
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Hematology/Oncology Clinic PLLC Baton Rouge Louisiana
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Billings Clinic Cancer Center Billings Montana
United States Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Bozeman Deaconess Hospital Bozeman Montana
United States Cox Cancer Center Branson Branson Missouri
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Roswell Park Cancer Institute Buffalo New York
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Saint Anthony Regional Hospital Carroll Iowa
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
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 Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Carle at The Riverfront Danville Illinois
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Institute at Saint Francis Hospital East Hills New York
United States Saint Elizabeth Healthcare Edgewood Edgewood Kentucky
United States Carle Physician Group-Effingham Effingham Illinois
United States Arnot Ogden Medical Center/Falck Cancer Center Elmira New York
United States Walter Knox Memorial Hospital Emmett Idaho
United States UC San Diego Health System - Encinitas Encinitas California
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Cancer Care and Hematology-Fort Collins Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Vanderbilt-Ingram Cancer Center at Franklin Franklin Tennessee
United States Vanderbilt-Ingram Cancer Center Cool Springs Franklin Tennessee
United States Central Care Cancer Center - Garden City Garden City Kansas
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States UCHealth Greeley Hospital Greeley Colorado
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Wayne Hospital Greenville Ohio
United States Memorial Sloan Kettering Westchester Harrison New York
United States Hartford Hospital Hartford Connecticut
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States First Dayton Cancer Care Kettering Ohio
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States UC San Diego Moores Cancer Center La Jolla California
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States CARTI Cancer Center Little Rock Arkansas
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Medical Center of the Rockies Loveland Colorado
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Community Medical Hospital Missoula Montana
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Monongalia Hospital Morgantown West Virginia
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Vanderbilt Breast Center at One Hundred Oaks Nashville Tennessee
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States The Hospital of Central Connecticut New Britain Connecticut
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Tulane University School of Medicine New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Lake Regional Hospital Osage Beach Missouri
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Women and Infants Hospital Providence Rhode Island
United States Reid Health Richmond Indiana
United States VCU Massey Cancer Center at Stony Point Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Highland Hospital Rochester New York
United States University of Rochester Rochester New York
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States University of Utah Sugarhouse Health Center Salt Lake City Utah
United States UC San Diego Medical Center - Hillcrest San Diego California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Sidney Kimmel Cancer Center Washington Township Sewell New Jersey
United States Welch Cancer Center Sheridan Wyoming
United States Robert Wood Johnson University Hospital Somerset Somerville New Jersey
United States Baystate Medical Center Springfield Massachusetts
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States State University of New York Upstate Medical University Syracuse New York
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Saint Joseph Warren Hospital Warren Ohio
United States Mercy Hospital Washington Washington Missouri
United States Sibley Memorial Hospital Washington District of Columbia
United States University of Cincinnati Cancer Center-West Chester West Chester Ohio
United States Methodist West Hospital West Des Moines Iowa
United States Good Samaritan University Hospital West Islip New York
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio

Sponsors (2)
Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of achieving the targeted carboplatin area under the curve (AUC) 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. Up to 4 weeks
Primary Precision of achieving the targeted carboplatin AUC 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. Up to 4 weeks
Primary Bias of the formula for estimated glomerular filtration rate (eGFR) currently in existence in patients with cancer 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. Up to 4 weeks
Primary Precision of the formula for eGFR currently in existence in patients with cancer 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. Up to 4 weeks
Primary Correlation between carboplatin clearance (CL) and mGFR 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. Up to 4 weeks
Secondary Divergence of eGFR from mGFR The bias of eGFR versus mGFR will be modeled as a function of the patient's characteristics. Up to 4 weeks
Secondary Success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped Among patients with eGFR > 125 mL/min, precision and bias will be estimated relative to the target carboplatin AUC. Up to 4 weeks
Secondary Relationship between carboplatin exposure and toxicity 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. Up to 4 weeks
Secondary Ability of markers in addition to creatinine in pre-treatment serum to better estimate kidney function in patients with cancer 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. Up to 4 weeks
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