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 Sex
- 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
Tucson 5318313, Arizona 5551752 85704
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Fort Smith 4111410, Arkansas 4099753 72903
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Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
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Encinitas 5346646, California 5332921 92024
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La Jolla 5363943, California 5332921 92093
Sacramento 5389489, California 5332921 95817
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San Diego 5391811, California 5332921 92103
Aurora 5412347, Colorado 5417618 80045
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Fort Collins 5577147, Colorado 5417618 80524
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Fort Collins 5577147, Colorado 5417618 80528
Greeley 5577592, Colorado 5417618 80631
Loveland 5579368, Colorado 5417618 80538
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Savannah 4221552, Georgia 4197000 31405
Boise 5586437, Idaho 5596512 83706
Caldwell 5587698, Idaho 5596512 83605
Coeur d'Alene 5589173, Idaho 5596512 83814
Meridian 5600685, Idaho 5596512 83642
Nampa 5601933, Idaho 5596512 83687
Post Falls 5604353, Idaho 5596512 83854
Sandpoint 5606401, Idaho 5596512 83864
Alton 4232679, Illinois 4896861 62002
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Centralia 4235587, Illinois 4896861 62801
Chicago 4887398, Illinois 4896861 60611
Danville 4889426, Illinois 4896861 61832
Effingham 4237727, Illinois 4896861 62401
Evanston 4891382, Illinois 4896861 60201
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Glenview 4893886, Illinois 4896861 60026
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Highland Park 4895876, Illinois 4896861 60035
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Mattoon 4244099, Illinois 4896861 61938
Mount Vernon 4245152, Illinois 4896861 62864
Normal 4903780, Illinois 4896861 61761
Normal 4903780, Illinois 4896861 61761
Urbana 4914570, Illinois 4896861 61801
Urbana 4914570, Illinois 4896861 61801
Richmond 4263681, Indiana 4921868 47374
Ankeny 4846960, Iowa 4862182 50023
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Carroll 4850478, Iowa 4862182 51401
Clive 4852065, Iowa 4862182 50325
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Des Moines 4853828, Iowa 4862182 50309
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Des Moines 4853828, Iowa 4862182 50314
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Fort Dodge 4857486, Iowa 4862182 50501
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Waukee 4880981, Iowa 4862182 50263
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West Des Moines 4881346, Iowa 4862182 50266-7700
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Garden City 5445439, Kansas 4273857 67846
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Baltimore 4347778, Maryland 4361885 21287
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Springfield 4951788, Massachusetts 6254926 01199
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Washington 4413621, Missouri 4398678 63090
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Anaconda 5637146, Montana 5667009 59711
Billings 5640350, Montana 5667009 59101
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Missoula 5666639, Montana 5667009 59804
Las Vegas 5506956, Nevada 5509151 89106
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West Chester 4520522, Ohio 5165418 45069
Youngstown 5177568, Ohio 5165418 44501
Oklahoma City 4544349, Oklahoma 4544379 73104
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Baker City 5712169, Oregon 5744337 97814
Ontario 5744166, Oregon 5744337 97914
Philadelphia 4560349, Pennsylvania 6254927 19107
Pittsburgh 5206379, Pennsylvania 6254927 15232
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Providence 5224151, Rhode Island 5224323 02905
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Bayamón 4562831, Puerto Rico 00959-5060
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San Juan 4568127, Puerto Rico 00936
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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.