Tumor Response to Pemetrexed Disodium in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Enrolled in Clinical Trial MCCRC-RC0524
Primary Purpose
Lung Cancer
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
gene expression analysis
polymorphism analysis
protein expression analysis
Sponsored by
About this trial
This is an observational trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Activity of pemetrexed disodium (PD) transport and activation enzymes as measured by intracellular content of PD polyglutamates
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00898820
First Posted
May 9, 2009
Last Updated
April 7, 2014
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00898820
Brief Title
Tumor Response to Pemetrexed Disodium in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Enrolled in Clinical Trial MCCRC-RC0524
Official Title
Predictive Markers of Response to Pemetrexed (Companion Study to RC0524)
Study Type
Observational
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
7. Study Design
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Primary Outcome Measure Information:
Title
Activity of pemetrexed disodium (PD) transport and activation enzymes as measured by intracellular content of PD polyglutamates
Secondary Outcome Measure Information:
Title
Polymorphisms and gene expression of PD target genes (RFC-1, MRP, folate receptor, FPGS, methylenetetrahydrofolate reductase, methionine synthase, methylthioadenosine phosphorylase, TS, DHFR, GARFT)
Title
Polymorphisms and gene expression of genes encoding enzymes involved in the transport, activation, and inactivation of PD
Title
Correlation of haplotype-tagged single-nucleotide polymorphisms (htSNPs) and gene expression levels with intracellular levels of PD polyglutamates
Title
Correlation of htSNPs and gene expression levels with toxicity and efficacy of PD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Molina, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elizabeth A. Johnson, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tumor Response to Pemetrexed Disodium in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Enrolled in Clinical Trial MCCRC-RC0524
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