The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) vs WBRT plus placebo. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.

Condition	Treatment or Intervention	Phase
Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Brain Neoplasms	Drug: Temozolomide	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

• Age greater than or equal to 18
• Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
• At least one brain metastasis diagnosed within 30 days of randomization
• Brain metastases must not have been previously treated with WBRT or radiosurgery
• No more than 2 sites of extracranial metastases
• May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites
• Meets protocol requirements for specified laboratory values.
• Written informed consent and cooperation of patient
• Appropriate use of effective contraception if of childbearing potential.
• Karnofsky Performance Status KPS greater than 70
• Score less than 2 on all criteria of the Comprehensive Neutrological Outcome Scale (CNOS)

Arizona
      Radiation Oncology Department, Tucson,  Arizona,  85724,  United States; Recruiting
California
      Sharp Memorial Hospital, San Diego,  California,  92123,  United States; Recruiting
      Cedars Sinai Cancer Center, Los Angeles,  California,  90048,  United States; Recruiting
Connecticut
      DeQuatto Community Cancer Center, Manchester,  Connecticut,  06040,  United States; Not yet recruiting
      Eastern CT Hem/Onc Associates, Norwich,  Connecticut,  06360,  United States; Not yet recruiting
Florida
      H. Lee Moffitt Cancer Center & Research Institute, Tampa,  Florida,  33612,  United States; Recruiting
      Bethesda Memorial Hospital, Boynton Beach,  Florida,  33435,  United States; Recruiting
      MD Anderson Cancer Center, Orlando,  Florida,  32806,  United States; Recruiting
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States; Recruiting
Georgia
      Emory University - Winship Cancer Center, Atlanta,  Georgia,  30322,  United States; Recruiting
      Medical Oncology Associations of Augusta, Augusta,  Georgia,  30901,  United States; Recruiting
Hawaii
      The Queen's Medical Center, Honolulu,  Hawaii,  96813,  United States; Recruiting
      Queen's Medical Hospital, Honolulu,  Hawaii,  United States; Recruiting
Idaho
      St. Luke's Mountain State Tumor, Boise,  Idaho,  83712,  United States; Recruiting
Illinois
      Kellogg Cancer Care Center/Evanston Hospital, Evanston,  Illinois,  60201,  United States; Not yet recruiting
Indiana
      Hematology Oncology of Indiana, Indianapolis,  Indiana,  46260,  United States; Recruiting
Kentucky
      James Brown Cancer Center, Louisville,  Kentucky,  40202,  United States; Recruiting
      Central Baptist Hospital, Lexington,  Kentucky,  40503,  United States; Recruiting
Louisiana
      Christus St. Francis Cabrini Medical Center, Alexandria,  Louisiana,  71301,  United States; Not yet recruiting
Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
Minnesota
      Metro-Minnesota Community Clinical Oncology Program, Minneapolis,  Minnesota,  55426,  United States; Not yet recruiting
New York
      New York Presbyterian Hospital, New York,  New York,  United States; Recruiting
      Dent Neurologic Institute, Amherst,  New York,  14226,  United States; Recruiting
      Memorial Sloan Kettering Cancer, New York,  New York,  United States; Recruiting
      Dent Neurologic Institute, Buffalo,  New York,  United States; Recruiting
North Carolina
      Southern Oncology Research, Greenville,  North Carolina,  27834,  United States; Recruiting
      Prebyterian Hospital Center for Cancer Research, Charlotte,  North Carolina,  28233,  United States; Recruiting
      Carolina NeuroSurgery & Spine Associates, Charlotte,  North Carolina,  28207,  United States; Recruiting
North Dakota
      Odyssey Research, Bismarck,  North Dakota,  58501,  United States; Recruiting
      Odyssey Research, Bismark,  North Dakota,  United States; Recruiting
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Not yet recruiting
Pennsylvania
      Thomas Jefferson University Hospital, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      University of Pittsburg Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Not yet recruiting
South Carolina
      Greenville CCOP Cancer Center, Greenville,  South Carolina,  29615,  United States; Recruiting
Tennessee
      Baptist Regional Hospital Cancer Center, Knoxville,  Tennessee,  37920,  United States; Recruiting
Texas
      Cancer Specialists of South Texas, Corpus Christi,  Texas,  78411,  United States; Recruiting
      Cancer Specialists of South Texas, Corpus Christi,  Texas,  United States; Recruiting
Washington
      Overlake Hospital Medical Center, Bellevue,  Washington,  98004,  United States; Recruiting
      Overlake Medical Hospital, Bellevue,  Washington,  United States; Recruiting

Study ID Numbers:  P03247
Record last reviewed:  February 2004
Record first received:  February 4, 2004
ClinicalTrials.gov Identifier:  NCT00076856
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10