RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Malignant Solid Neoplasm
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona Cancer Center-Orange Grove Campus, Tucson, Arizona, United States, 85704

Tucson

Banner University Medical Center - Tucson, Tucson, Arizona, United States, 85719

Tucson

University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States, 85719

Fort Smith

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States, 72903

Little Rock

CARTI Cancer Center, Little Rock, Arkansas, United States, 72205

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Encinitas

UC San Diego Health System - Encinitas, Encinitas, California, United States, 92024

La Jolla

UC San Diego Moores Cancer Center, La Jolla, California, United States, 92093

Sacramento

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States, 95817

San Diego

UC San Diego Medical Center - Hillcrest, San Diego, California, United States, 92103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

NRG Oncology,

Sarah E Taylor, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

2028-02-06