Solid TumorNCT00898027
Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer
An observational study of Solid Tumor, run by Vanderbilt-Ingram Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- laboratory biomarker analysis
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis
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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- laboratory biomarker analysis
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
laboratory biomarker analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of EGFR inhibitors on magnesium homeostasis
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2006
- Primary completionMar 2008
- Study completionFeb 2009
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Laura Goff, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898027
- Sponsor's protocol ID
- VICC GI 0615
- Other IDs
- VU-VICC-GI-0615, VU-VICC-IRB-060364
- Status last verified
- Jan 2013
- First submitted
- 9 May 2009
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis
- ClinicalTrials.gov ID
- NCT00898027
- Acronym / sponsor ID
- VICC GI 0615
- Conditions
- Solid Tumor
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- May 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of malignancy
- Normal serum magnesium level
Key exclusion criteria (6 listed)
- Glomerular filtration rate ≥ 60 mL/min
- No severe underlying renal dysfunction
- Normal serum potassium and calcium level
- No history of primary or secondary hyperparathyroidism
- No prior EGFR pathway inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysislaboratory biomarker analysis | Other | – |
Primary outcome
Effects of EGFR inhibitors on magnesium homeostasis
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Goff, MD principal investigator
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, run by Vanderbilt-Ingram Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of EGFR inhibitors on magnesium homeostasis (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.