Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer

This study has been terminated.
(slow accrual)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00898027
First received: May 9, 2009
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer receiving epidermal growth factor receptor inhibitors may help doctors understand the effect of epidermal growth factor receptor inhibitors on magnesium levels in the body.

PURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor inhibitors on magnesium homeostasis in patients with cancer.


Condition Intervention
Solid Tumor
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Effects of EGFR inhibitors on magnesium homeostasis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: May 2006
Study Completion Date: February 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: laboratory biomarker analysis
    laboratory biomarker analysis
    Other Name: laboratory biomarker analysis
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Individuals with the diagnosis of a malignancy for which they are considering therapy with an inhibitor of the EGFR pathway, have received an inhibitor of the EGFR pathway prior to study start, have no severe underlying renal dysfunction as defined as estimated GFR<60 by MDRD equation and must be ≥ 18 years of age.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898027

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Laura Goff, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Laura W. Goff, MD, Assistant Professor of Medicine; Associate Director, Hematology/Oncology, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00898027     History of Changes
Other Study ID Numbers: VICC GI 0615, VU-VICC-GI-0615, VU-VICC-IRB-060364
Study First Received: May 9, 2009
Last Updated: January 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014