Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis
18 Years
N/A
Both
Solid Tumor
Trial Information
Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis
OBJECTIVES:
- Determine the effects of EGFR inhibitors on magnesium homeostasis in patients with
cancer.
OUTLINE: This is a pilot study.
Patients undergo blood and urine sample collection at baseline and at 2, 4, and 8 weeks
during treatment.
After finishing treatment, patients are followed periodically for up to 10 weeks.
Inclusion Criteria:
- Diagnosis of malignancy
- Planning to receive therapy with an inhibitor of the EGFR pathway (either on or
off a clinical trial and may be monotherapy or combined with other therapies)
- Normal serum magnesium level
Exclusion Criteria:
- Glomerular filtration rate ≥ 60 mL/min
- No severe underlying renal dysfunction
- Normal serum potassium and calcium level
- No history of primary or secondary hyperparathyroidism
PRIOR CONCURRENT THERAPY:
- No prior EGFR pathway inhibitor
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Effects of EGFR inhibitors on magnesium homeostasis
Outcome Time Frame:
8 weeks
Safety Issue:
No
Principal Investigator
Laura Goff, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Federal Government
Study ID:
VICC GI 0615
NCT ID:
NCT00898027
Start Date:
May 2006
Completion Date:
February 2009
Related Keywords:
- Solid Tumor
- unspecified adult solid tumor, protocol specific
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