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Back|NCT03997370Recruiting
Official Title

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

Phase
Phase 1
Sponsor
NRG Oncology
Enrollment
350
Timeline
Jan 2020 → Feb 2028
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • 2For men who are sexually active, the need for use of medically acceptable contraception will be dictated by the primary treatment plan/protocol
  • 3Study 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)
  • 4Male sex
  • 5Any 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
  • 6Age \>= 18
  • 7The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria

  • 1Treated at an institute where creatinine is not measured with an IDMS calibrated assay
  • 2History of allergic reactions to computed tomography (CT) contrast, iodine or shellfish, or history of anaphylactic reaction to any food item
  • 3Recent (last 6 months) episode of acute kidney injury, have sickle cell disease, or have current indwelling nephrostomy tubes
  • 4Edema beyond trace edema, because this will impact iohexol equilibration and distribution
  • 5Ascites (including pleural effusion) beyond trace ascites, because this will impact iohexol equilibration and distribution
  • 6Whole- or part-limb amputees, because this will impact iohexol equilibration and distribution
  • 7Inability 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)
  • 8Inadequate venous access to obtain pharmacokinetic (PK) specimens
  • 9Multinodular goiter, Graves' disease or autoimmune thyroiditis, per iohexol package insert (hypothyroidism is allowed)

Locations

187 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Active, Not Recruiting

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Active, Not Recruiting

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona 85704

Recruiting

Setsuko K. Chambers

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →