What side effects are associated with this type of intervention?

Common cancer treatments, particularly chemotherapy agents like carboplatin, are associated with several side effects. Hematologic toxicities such as neutropenia, thrombocytopenia, and anemia are frequent. Non-hematologic side effects include nausea, vomiting, nephrotoxicity, and neurotoxicity. Oxaliplatin can cause peripheral neuropathy, while fluorouracil (FU) often leads to gastrointestinal issues like diarrhea and mucositis. Capecitabine is known for causing hand-foot syndrome and fatigue. These side effects can significantly impact patients' quality of life and treatment adherence.

What prior FDA approvals exist?

The FDA has approved several chemotherapy agents and combinations for the treatment of various cancers. Carboplatin, often used in combination with paclitaxel, is a standard treatment for ovarian, lung, and other cancers. The combination of carboplatin and paclitaxel has been shown to be effective, although it can cause significant hematologic toxicity. Other related FDA-approved drugs include cisplatin, another platinum-based chemotherapy agent, and bevacizumab, a monoclonal antibody that can be combined with chemotherapy for enhanced efficacy. These treatments aim to stop tumor growth by killing cancer cells, preventing their division, or inhibiting their spread.

What other types of research exist?

The provided documents do not specify any novel alternatives to Iohexol for accurate kidney function measurements to optimize carboplatin dosing. It is recommended to consult with a healthcare provider for the most current and personalized medical advice.

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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

Must not have

Recent (last 6 months) episode of acute kidney injury, have sickle cell disease, or have current indwelling nephrostomy tubes

Ascites (including pleural effusion) beyond trace ascites, because this will impact iohexol equilibration and distribution

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well iohexol helps doctors calculate the dose of carboplatin for cancer patients. By measuring kidney function more accurately, doctors can improve the effectiveness and safety of carboplatin treatment. Carboplatin is a platinum-based chemotherapy drug used to treat various cancers, known for its improved toxicity profile compared to cisplatin.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had a recent kidney injury, have sickle cell disease, or currently use nephrostomy tubes.

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I do not have significant fluid buildup in my abdomen or chest.

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I have poor vein access for blood draws.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6120

Biospecimen Collection

2004

Completed Phase 3

~2020

0 / 7Eligibility criteria met

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.