Prospective Analysis of Genotypes in Adults Undergoing Therapy for Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923884
First received: June 17, 2009
Last updated: August 1, 2014
Last verified: July 2014
  Purpose

Background:

  • The Lung Cancer section of the National Cancer Institute s Medical Oncology Branch is running a study to better understand which genes might be important in patients who are undergoing therapy for lung cancer.

Objectives:

  • To find out if differences (also called polymorphisms) in specific genes lead to differences in outcomes (such as treatment success and survival rates) for patients who have been diagnosed with lung cancer.
  • To establish a repository of genetic information for future studies of these differences and their relation to lung cancer.

Eligibility:

  • Any individual who has been diagnosed with lung cancer and is being treated through the National Cancer Institute.

Design:

  • After entrance in this study, patients will provide information to the researchers on age, gender, race/ethnicity, treatments received and response to treatments, and other specific information about their disease. This information will be kept confidential.
  • Approximately half a tablespoon of blood will be drawn.
  • Patients will be treated for lung cancer with normal treatment methods, as if they had not been enrolled in the study
  • Some patients may be offered the option of enrolling in separate research protocols for cancer treatment, involving chemotherapy, surgery, or radiation.

Condition
Carcinoma, Non-Small Cell Lung
Carcinoma, Small-Cell Lung

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Analysis of Genotypes in Adults Undergoing Therapy for Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Evaluation of the association between polymorphisms in the enzymes ABCB1, CYP1B1, and CYP19 and clinical outcomes, with overall survival of greatest interest, in patients undergoing treatment for lung cancer. [ Time Frame: Death or the conclusion of a 5-year follow-up period ] [ Designated as safety issue: No ]

Enrollment: 442
Study Start Date: March 2009
Detailed Description:

Background:

  • Lung cancer is the leading cause of cancer deaths among men and women worldwide.
  • Despite modern surgical, radiation, and chemotherapeutic interventions, the prognosis for patients with lung cancer remains poor, with an overall cure rate of less than 15%.
  • Genetic polymorphisms in drug-metabolizing enzymes, transporters, growth factor and hormonal receptors, DNA repair enzymes, and transcription factors might affect an individual s response to chemotherapy and radiation.
  • Interindividual differences in efficacy and toxicity of cancer chemotherapy and radiation are especially important given the narrow therapeutic index of these modalities.
  • Many of these differences have not been extensively explored in patients with lung cancer.

Objectives:

  • To better understand the genotype-phenotype relationship between genetic polymorphisms and clinical outcomes, with a focus on overall survival, following lung cancer therapy.
  • To better understand differences in outcome between Caucasian and African American patients being treated for lung cancer as a function of genotype.
  • To establish a DNA repository for the investigation of polymorphisms related to outcomes in lung cancer.
  • To develop methodology for the isolation, enumeration and live cell culture of circulating tumor cells (CTC) from lung cancer patients with microfiltration devices.

Eligibility:

- All individuals with the diagnosis of lung cancer being treated at the Washington D.C. Veteran s Affairs Hospital, Washington Hospital Center (WHC) or the Medical Oncology Branch of the National Cancer Institute (NCI).

Design:

  • A single 7-ml sample of venous blood will be obtained from all patients enrolled onto this study, for isolation of DNA.
  • Two 5 ml samples of venous blood, drawn immediately following the 7 ml sample, will be obtained from all patients enrolled on this study at the NCI Clinical Center (only), for CTC studies.
  • Polymorphisms in the following genes: ABCB1, ABCG2, COMT, CYP17, CYP19, CYP1B1, CYP1A1, CYP1A2, CYP2C8, CYP2C9, CYP2J2, CYP3A4, CYP3A5, DPYD, EPHX2, ERalpha, ERbeta, ERCC1, ERCC2, GSTP1, HIF1A, MPO, MTHFR, NQO1, p53, PPARD, SLCO1B3, TYMS, UGT1A1, VEGF, VEGFR, EGFR, SLC28A1, CDA, XRCC1, OCT1, and OCT2 will be analyzed by the Clinical Pharmacology Program.
  • Methodology for the isolation, enumeration, and live cell culture of CTC with microfiltration devices will be developed by the NCI Genetics Branch.
  • Patients will be followed at the medical oncology clinic at the Washington DC VA Hospital, WHC, or the NCI and the following information will be recorded in a confidential database: age, gender, race/ethnicity, smoking history, histology, stage, treatment(s) received, response, toxicity (grades 3-5), time to disease progression, time to death.
  • Associations between genetic polymorphisms and response to therapy, toxicity and clinical outcomes will be analyzed.
  • The results of the CTC studies will be applied to the initial development and clinical

validation of CTC technology and lung cancer assays.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Patients 18 years of age and older are eligible.
    2. Histologic diagnosis of primary lung carcinoma. For non small cell lung cancer, patients can be stage I to IV, and receive any treatment (surgical resection, chemotherapy, radiation, molecularly targeted therapy). For small cell lung cancer, patients can be limited or extensive stage and receive any treatment (surgical resection, chemotherapy, radiation, molecularly targeted therapy).
    3. Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
    4. Patients with a current diagnosis of or a prior history of other cancers may be included onto this protocol.
    5. Patients may have either normal organ function or impaired organ function.

EXCLUSION CRITERIA:

1. Children will not be eligible.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923884

Locations
United States, District of Columbia
VA Medical Center, Washington D.C.
Washington, District of Columbia, United States, 20422
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Arun Rajan, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00923884     History of Changes
Other Study ID Numbers: 090103, 09-C-0103
Study First Received: June 17, 2009
Last Updated: August 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
NSCLC
Genotype
SCLC
Lung Cancer
Non-Small Cell Lung Cancer
Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014