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

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898027
First Posted: May 12, 2009
Last Update Posted: January 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
  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 Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Effects of EGFR inhibitors on magnesium homeostasis [ Time Frame: 8 weeks ]

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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898027


Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Laura Goff, MD Vanderbilt-Ingram Cancer Center
  More Information

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
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center:
unspecified adult solid tumor, protocol specific

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