Tumor Response to Pemetrexed Disodium in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Enrolled in Clinical Trial MCCRC-RC0524
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Genetic: gene expression analysis Genetic: polymorphism analysis Genetic: protein expression analysis |
| Study Type: | Observational |
| Official Title: | Predictive Markers of Response to Pemetrexed (Companion Study to RC0524) |
- Activity of pemetrexed disodium (PD) transport and activation enzymes as measured by intracellular content of PD polyglutamates [ Designated as safety issue: No ]
- Polymorphisms and gene expression of PD target genes (RFC-1, MRP, folate receptor, FPGS, methylenetetrahydrofolate reductase, methionine synthase, methylthioadenosine phosphorylase, TS, DHFR, GARFT) [ Designated as safety issue: No ]
- Polymorphisms and gene expression of genes encoding enzymes involved in the transport, activation, and inactivation of PD [ Designated as safety issue: No ]
- Correlation of haplotype-tagged single-nucleotide polymorphisms (htSNPs) and gene expression levels with intracellular levels of PD polyglutamates [ Designated as safety issue: No ]
- Correlation of htSNPs and gene expression levels with toxicity and efficacy of PD [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00898820 History of Changes |
| Other Study ID Numbers: | CDR0000517066, MCCRC-RC0527 |
| Study First Received: | May 9, 2009 |
| Last Updated: | May 16, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 21, 2013