A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

Foundation for the National Institutes of Health

Status: Unknown

Conditions: Head and Neck Cancer

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT01936376

Kidney Safety - Cisplatin

Details and patient eligibility

About

The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

Full description

The study will be conducted at four major medical centers, including the University of Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the MD Anderson Cancer Center. Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Cisplatin Treatment Group):

1. Males and females ≥ 18 years of age

2. Diagnosis of head & neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:

   • as single agent chemotherapy in conjunction with local radiotherapy course, or
   • as part of the TPF combination (docetaxel, cisplatin, and fluorouracil)

3. Willingness and ability to comply with study procedures and study restrictions

4. Ability to provide written informed consent

Inclusion Criteria (Control Group):

1. Males and females ≥ 18 years of age
2. Diagnosis of head & neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone)
3. Willingness and ability to comply with study procedures and study restrictions
4. Ability to provide written informed consent

Exclusion Criteria (All Subjects):

1. Chronic kidney disease defined by eGFR <60 mL/min/1.73m2. Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement: those with microalbuminuria (>30 mcg/mg creatinine) will be excluded
2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)
3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month
4. Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine
5. Use of creatine supplements within 7 days prior to hospitalization
6. Solid organ transplant recipients
7. Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)
8. Significant anemia (Hemoglobin < 10 g/dL)
9. Pregnancy
10. Institutionalized individuals

Trial design

150 participants in 2 patient groups

head & neck cancer patients, cisplatin treatment

cancer patients, no cisplatin, no nephrotoxic agent