Tumor Response to Pemetrexed Disodium in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Enrolled in Clinical Trial MCCRC-RC0524
NCT ID: NCT00898820
Last Updated: 2014-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2006-11-30
2007-12-31
Brief Summary
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PURPOSE: This laboratory study is looking at blood samples from patients with stage III or stage IV non-small cell lung cancer enrolled in clinical trial MCCRC-RC0524 to determine the effect of pemetrexed disodium on cells.
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Detailed Description
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Primary
* Assess the intracellular level of pemetrexed disodium (PD) polyglutamates as a measure of activity of PD transport and activation enzymes in patients with stage III or IV non-small cell lung cancer enrolled in clinical trial MCCRC-RC0524.
Secondary
* Assess polymorphisms and gene expression of PD target genes and genes encoding enzymes involved in the transport, activation, and inactivation of PD in these patients.
* Correlate haplotype-tagged single-nucleotide polymorphisms (htSNPs) and gene expression levels with intracellular levels of PD polyglutamates
* Correlate htSNPs and gene expression levels with toxicity and efficacy of PD.
OUTLINE: Blood is drawn prior to and 24 hours after day 1 of course 1 of pemetrexed disodium. DNA is extracted and genotyped for known polymorphisms in genes involved in the transport, activation, inactivation, and mechanism of action or resistance of pemetrexed disodium, including reduced folate carrier-1, multiresistance proteins (particularly MRP5), folate receptor, folypolyglutamate synthase, methylenetetrahydrofolate reductase (MTHFR), methionine synthase, methylthioadenosine phosphorylase, thymidylate synthase (TS), dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase. Plasma and red blood cells are also processed for an intracellular polyglutamate assay for pemetrexed disodium by a high-performance liquid chromatography-based method.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Conditions
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Interventions
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gene expression analysis
polymorphism analysis
protein expression analysis
Eligibility Criteria
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Inclusion Criteria
* Enrolled in clinical trial MCCRC-RC0524
* Willing to provide blood samples
PATIENT CHARACTERISTICS:
* No investigator site personnel directly affiliated with the study, or immediate family of investigator site personnel directly affiliated with the study
* Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
* Not employed by Eli Lilly (i.e., employee, temporary contract worker, or designee responsible for conducting the study)
* Immediate family of Eli Lilly employees allowed, but may not participate at an Eli Lilly facility
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic Cancer Center
Principal Investigators
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Julian Molina, MD, PhD
Role: STUDY_CHAIR
Mayo Clinic
Elizabeth A. Johnson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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RC0527
Identifier Type: OTHER
Identifier Source: secondary_id
06-002282
Identifier Type: OTHER
Identifier Source: secondary_id
RC0527
Identifier Type: -
Identifier Source: org_study_id
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