NCT00898027

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2006

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

May 9, 2009

Last Update Submit

January 28, 2013

Conditions

Solid Tumor

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Effects of EGFR inhibitors on magnesium homeostasis

    8 weeks

Interventions

laboratory biomarker analysisOTHER

laboratory biomarker analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Laura Goff, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine; Associate Director, Hematology/Oncology

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2006

Primary Completion

March 1, 2008

Study Completion

February 1, 2009

Last Updated

January 29, 2013

Record last verified: 2013-01