Protocol Number: 09-C-0103

Title:

Prospective Analysis of Genotypes in Adults Undergoing Therapy for Lung Cancer

Number:

09-C-0103

Summary:

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.

Eligibility:

- All individuals with the diagnosis of lung cancer being treated at the Washington D.C. Veteran's Affairs Hospital or the Medical Oncology Branch of the National Cancer Institute.

Design:

- A single 7 ml sample of venous blood will be obtained from all patients enrolled onto this study, for isolation of DNA.

- 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.

- Patients will be followed at the medical oncology clinic at the Washington DC VA Hospital or the National Cancer Institute 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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

NSCLC

Genotype

SCLC

Recruitment Keyword(s):

None

Condition(s):

NSCLC

SCLC

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96.

Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J; International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004 Jan 22;350(4):351-60.

Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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