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

NCT01936376

Last updated date
Study Location
Harvard Medical School - Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Head and Neck Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

(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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

(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

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Head and Neck CancerA Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
NCT01936376
  1. Boston, Massachusetts
  2. Boston, Massachusetts
  3. Houston, Texas
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18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
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
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
urine and blood
Sampling Method Probability Sample
Study Population cancer patients
Condition Head and Neck Cancer
Intervention Not Provided
Study Groups/Cohorts
  • head & neck cancer patients, cisplatin treatment
  • cancer patients, no cisplatin, no nephrotoxic agent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 3, 2013)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01936376
Other Study ID Numbers Kidney Safety - Cisplatin
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Foundation for the National Institutes of Health
Study Sponsor Foundation for the National Institutes of Health
Collaborators
  • University of Southern California
  • University of Minnesota
  • M.D. Anderson Cancer Center
  • Brigham and Women's Hospital
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Amgen
  • AstraZeneca
  • Eli Lilly and Company
  • Johnson & Johnson
  • Merck Sharp & Dohme Corp.
  • Pfizer
  • Critical Path Institute - Predictive Safety Testing Consortium
Investigators
Principal Investigator:Abdulla Salahudeen, MDUniversity of Texas MD Anderson
Principal Investigator:Sushrut Waikar, MDDana-Farber Cancer Institute
PRS Account Foundation for the National Institutes of Health
Verification Date July 2014