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Alkylating agents

Iohexol-aided Carboplatin Dosing for Cancer

Phase 1
Recruiting
Led By Sarah E Taylor
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18
Male sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Study Summary

This trial is testing whether iohexol can help doctors calculate the dose of carboplatin given to cancer patients.

Who is the study for?
This trial is for male cancer patients aged 18 or older who will receive carboplatin chemotherapy. They must be in good general health, able to follow the study plan, and provide informed consent. Men should use contraception as dictated by their treatment protocol. Women are not eligible due to study objectives.Check my eligibility
What is being tested?
The trial is testing how well iohexol helps calculate the correct dose of carboplatin for cancer treatment. It aims to improve dosing accuracy of carboplatin by studying its interaction with iohexol and collecting biospecimens from participants.See study design
What are the potential side effects?
Potential side effects may include allergic reactions related to iohexol (similar to those seen with CT contrast agents), issues affecting kidney function, and possible interference with thyroid gland activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am male.
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I am a male interested in joining the study.
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I will be treated with carboplatin through a clinical trial or as standard care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of achieving the targeted carboplatin area under the curve (AUC)
Bias of the formula for estimated glomerular filtration rate (eGFR) currently in existence in patients with cancer
Correlation between carboplatin clearance (CL) and mGFR
+2 more
Secondary outcome measures
Ability of markers in addition to creatinine in pre-treatment serum to better estimate kidney function in patients with cancer
Divergence of eGFR from mGFR
Relationship between carboplatin exposure and toxicity
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (iohexol, standard care carboplatin, blood samples)Experimental Treatment3 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Iohexol
2016
Completed Phase 4
~1920
Carboplatin
2014
Completed Phase 3
~6670
Biospecimen Collection
2004
Completed Phase 2
~1720

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Chemotherapy drugs, such as carboplatin, function by disrupting the DNA of cancer cells, thereby inhibiting their ability to divide and proliferate. This mechanism is vital for cancer patients as it targets rapidly growing tumor cells. Accurate dosing of these drugs is critical to enhance their effectiveness and minimize adverse effects. Iohexol aids in this by providing precise kidney function measurements, allowing for the optimization of carboplatin dosing tailored to each patient's renal function. This personalized dosing approach can lead to better treatment outcomes and reduced toxicity.
Metabolic design of combination therapy: use of enhanced fluorodeoxyglucose uptake caused by chemotherapy.Selecting drug combinations based on total equivalent dose (dose intensity)The chemotherapy of prostatic adenocarcinoma.

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
232 Previous Clinical Trials
100,399 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,743 Previous Clinical Trials
40,957,497 Total Patients Enrolled
Sarah E TaylorPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
22 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03997370 — Phase 1
Cancer Research Study Groups: Treatment (iohexol, standard care carboplatin, blood samples)
Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03997370 — Phase 1
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03997370 — Phase 1
~129 spots leftby Feb 2027