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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01936376
• Other study ID #: Kidney Safety - Cisplatin
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2013
• Last updated: January 23, 2015
• Start date: September 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2014
• Source: Foundation for the National Institutes of Health
• Contact: Stefan Sultana, MD
• Email: stefan.sultana[@]novartis.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Harvard Medical School - Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Texas MD Anderson	Houston	Texas

Sponsors (13)

Lead Sponsor	Collaborator
Foundation for the National Institutes of Health	Amgen, AstraZeneca, Brigham and Women's Hospital, Critical Path Institute - Predictive Safety Testing Consortium, Eli Lilly and Company, Johnson & Johnson, M.D. Anderson Cancer Center, Merck Sharp & Dohme Corp., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pfizer, University of Minnesota - Clinical and Translational Science Institute, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biomarker change from baseline		up to 3 weeks	No