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Tumor Response to Pemetrexed Disodium in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Enrolled in Clinical Trial MCCRC-RC0524

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898820
First Posted: May 12, 2009
Last Update Posted: April 9, 2014
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
May 9, 2009
May 12, 2009
April 9, 2014
November 2006
December 2007   (Final data collection date for primary outcome measure)
Activity of pemetrexed disodium (PD) transport and activation enzymes as measured by intracellular content of PD polyglutamates
Same as current
Complete list of historical versions of study NCT00898820 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Same as current
Not Provided
Not Provided
 
Tumor Response to Pemetrexed Disodium in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Enrolled in Clinical Trial MCCRC-RC0524
Predictive Markers of Response to Pemetrexed (Companion Study to RC0524)

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

  • 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.

Observational
Not Provided
Not Provided
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Lung Cancer
  • Genetic: gene expression analysis
  • Genetic: polymorphism analysis
  • Genetic: protein expression analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2007
December 2007   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00898820
RC0527
P30CA015083 ( U.S. NIH Grant/Contract )
RC0527 ( Other Identifier: Mayo Clinic Cancer Center & MCCRC )
06-002282 ( Other Identifier: Mayo Clinic IRB )
Yes
Not Provided
Not Provided
Julian R. Molina, M.D., Ph.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Julian Molina, MD, PhD Mayo Clinic
Principal Investigator: Elizabeth A. Johnson, M.D. Mayo Clinic
Mayo Clinic
April 2014
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