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

NCT00898820 | Completed DMC

• 3 other identifiers: RC0527P30CA01508306-002282
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Activity of pemetrexed disodium (PD) transport and activation enzymes as measured by intracellular content of PD polyglutamates

Secondary Outcomes (4)

• 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

Interventions

gene expression analysis GENETIC

polymorphism analysis GENETIC

protein expression analysis GENETIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gene Expression Profiling; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Julian Molina, MD, PhD

  Mayo Clinic

  STUDY CHAIR

• Elizabeth A. Johnson, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: November 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

US (1)