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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| RC0527 | Other Identifier | Mayo Clinic Cancer Center & MCCRC | |
| 06-002282 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Studying samples of blood in the laboratory from patients receiving pemetrexed disodium may help doctors learn more about the effects of pemetrexed disodium on cells. It may also help doctors understand how well patients respond to treatment.
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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene expression analysis | Genetic | |||
| polymorphism analysis | Genetic | |||
| protein expression analysis | Genetic |
| Measure | Description | Time Frame |
|---|---|---|
| Activity of pemetrexed disodium (PD) transport and activation enzymes as measured by intracellular content of PD polyglutamates |
| Measure | Description | Time Frame |
|---|---|---|
| Polymorphisms and gene expression of PD target genes (RFC-1, MRP, folate receptor, FPGS, methylenetetrahydrofolate reductase, methionine synthase, methylthioadenosine phosphorylase, TS, DHFR, GARFT) | ||
| Polymorphisms and gene expression of genes encoding enzymes involved in the transport, activation, and inactivation of PD |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No investigator site personnel directly affiliated with the study, or immediate family of investigator site personnel directly affiliated with the study
Not employed by Eli Lilly (i.e., employee, temporary contract worker, or designee responsible for conducting the study)
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Molina, MD, PhD | Mayo Clinic | Study Chair |
| Elizabeth A. Johnson, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Correlation of haplotype-tagged single-nucleotide polymorphisms (htSNPs) and gene expression levels with intracellular levels of PD polyglutamates |
| Correlation of htSNPs and gene expression levels with toxicity and efficacy of PD |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016172 | DNA Fingerprinting |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
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