The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in patients with advanced non-small cell lung cancer who have received one previous chemotherapy.

Condition	Treatment or Intervention	Phase
Non-small cell lung cancer	Drug: Two FDA approved chemotherapy drugs	Phase III

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

Criteria

Inclusion Criteria (subjects must meet the following criteria in order to be considered eligible for this study) :

• Written informed consent
• Confirmed advanced non-small cell lung carcinoma (NSCLC)
• Received one prior chemotherapy for metastatic NSCLC. In addition, patients are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor.
• Presence of either measurable or non-measurable disease by radiologic study or physical examination.
• Full recovery and at least 21 days from prior treatment for NSCLC.
• At least 3 weeks since last major surgery (lesser period is acceptable if deemed in the best interest of the patient).
• At least 7 days since prior radiotherapy.
• Adequate bone marrow reserve, and adequate kidney and liver function.

Exclusion Criteria (subjects cannot meet the following criteria in order to be considered eligible for this study):

• Symptoms of brain metastases requiring treatment with steroids.
• Active infection.
• Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
• Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
• Use of investigational drug within 30 days prior to the first dose of study medication.
• Women who are pregnant or lactating.
• Patients of child-bearing potential refusing to practice adequate contraception.
• Patients who cannot receive steroid premedication.

Alabama
      Huntsville,  Alabama,  35801,  United States; Recruiting
      Mobile,  Alabama,  36608,  United States; Recruiting
Arizona
      Little Rock,  Arizona,  72205,  United States; Terminated
      Phoenix,  Arizona,  85012,  United States; Terminated
      Tucson,  Arizona,  85715,  United States; Recruiting
California
      Rancho Mirage,  California,  85006,  United States; Terminated
      Los Angeles,  California,  90067,  United States; Recruiting
      Poway,  California,  92064,  United States; Recruiting
      San Diego,  California,  92093,  United States; Terminated
      Fresno,  California,  93720,  United States; Terminated
      Los Gatos,  California,  95032,  United States; Terminated
Colorado
      Englewood,  Colorado,  80110,  United States; Terminated
      Denver,  Colorado,  80201,  United States; Recruiting
      Boulder,  Colorado,  80304,  United States; Terminated
      Greeley,  Colorado,  80631,  United States; Terminated
District of Columbia
      Washington,  District of Columbia,  20307,  United States; Recruiting
      Washington,  District of Columbia,  20422,  United States; Recruiting
Florida
      Orange Park,  Florida,  32073,  United States; Recruiting
      Jacksonville,  Florida,  32207,  United States; Terminated
      Orlando,  Florida,  32804,  United States; Recruiting
      Miami Shores,  Florida,  33138,  United States; Recruiting
      Boca Raton,  Florida,  33428,  United States; Terminated
      Boca Raton,  Florida,  33486,  United States; Recruiting
      Tampa,  Florida,  33612,  United States; Recruiting
      Stuart,  Florida,  34994,  United States; Recruiting
Georgia
      Columbus,  Georgia,  31902,  United States; Terminated
Idaho
      Idaho Falls,  Idaho,  83404,  United States; Terminated
Illinois
      Elk Grove Village,  Illinois,  60007,  United States; Recruiting
      Skokie,  Illinois,  60077,  United States; Recruiting
      Urbana,  Illinois,  61801,  United States; Recruiting
      Decatur,  Illinois,  62526,  United States; Recruiting
Indiana
      Indianapolis,  Indiana,  46202,  United States; Recruiting
Kentucky
      Louisville,  Kentucky,  40207,  United States; Recruiting
      Louisville,  Kentucky,  40215,  United States; Recruiting
      Bowling Green,  Kentucky,  42101,  United States; Recruiting
Louisiana
      Lafayette,  Louisiana,  70506,  United States; Recruiting
      Lake Charles,  Louisiana,  70601,  United States; Recruiting
      Baton Rouge,  Louisiana,  70821,  United States; Recruiting
Maryland
      Frederick,  Maryland,  21701,  United States; Recruiting
Massachusetts
      Boston,  Massachusetts,  02118,  United States; Recruiting
Michigan
      Royal Oak,  Michigan,  48073,  United States; Terminated
      Grosse Pointe Woods,  Michigan,  48230,  United States; Recruiting
Minnesota
      Minneapolis,  Minnesota,  55407,  United States; Recruiting
      Minneapolis,  Minnesota,  55417,  United States; Recruiting
      Minneapolis,  Minnesota,  55417,  United States; Terminated
      Robbinsdale,  Minnesota,  55422,  United States; Terminated
      St. Louis Park,  Minnesota,  55426,  United States; Recruiting
      Minneapolis,  Minnesota,  55426,  United States; Terminated
Missouri
      St. Louis,  Missouri,  63141,  United States; Recruiting
      Springfield,  Missouri,  65807,  United States; Recruiting
Nevada
      Las Vegas,  Nevada,  89106,  United States; Recruiting
      Reno,  Nevada,  89502,  United States; Recruiting
New Jersey
      Hackensack,  New Jersey,  07601,  United States; Recruiting
      Cherry Hill,  New Jersey,  08003,  United States; Terminated
New York
      Bronx,  New York,  10467,  United States; Recruiting
      Nyack,  New York,  10956,  United States; Recruiting
      Manhasset,  New York,  11030,  United States; Recruiting
      New Hyde Park,  New York,  11040,  United States; Recruiting
      Brooklyn,  New York,  11220,  United States; Terminated
      East Syracuse,  New York,  13057,  United States; Recruiting
      Buffalo,  New York,  14215,  United States; Recruiting
      Rochester,  New York,  14623,  United States; Recruiting
North Carolina
      Winston Salem,  North Carolina,  27103,  United States; Recruiting
      High Point,  North Carolina,  27262,  United States; Terminated
      Greenville,  North Carolina,  27835,  United States; Terminated
      Greenville,  North Carolina,  27858,  United States; Terminated
      Fayetteville,  North Carolina,  28302,  United States; Recruiting
North Dakota
      Fargo,  North Dakota,  58122,  United States; Terminated
Ohio
      Canton,  Ohio,  44718,  United States; Recruiting
Pennsylvania
      Dunmore,  Pennsylvania,  18512,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19114,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19114,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19140,  United States; Not yet recruiting
South Carolina
      Columbia,  South Carolina,  29203,  United States; Recruiting
      Spartanburg,  South Carolina,  29303,  United States; Recruiting
      Mt. Pleasant,  South Carolina,  29464,  United States; Terminated
      Hilton Head,  South Carolina,  29926,  United States; Recruiting
Tennessee
      Nashville,  Tennessee,  37203,  United States; Recruiting
      Nashville,  Tennessee,  37232,  United States; Not yet recruiting
      Knoxville,  Tennessee,  37916,  United States; Recruiting
Texas
      Irving,  Texas,  75038,  United States; Recruiting
      Tyler,  Texas,  75701,  United States; Recruiting
      Tyler,  Texas,  75701,  United States; Recruiting
Virginia
      Norfolk,  Virginia,  23502,  United States; Terminated
      Norfolk,  Virginia,  23507,  United States; Recruiting
      Newport News,  Virginia,  23606,  United States; Recruiting
      Abingdon,  Virginia,  24211,  United States; Recruiting
Washington
      Tacoma,  Washington,  98405,  United States; Recruiting
      Spokane,  Washington,  99220,  United States; Recruiting
Wisconsin
      Sheboygan,  Wisconsin,  53081,  United States; Recruiting
      Milwaukee,  Wisconsin,  53215,  United States; Terminated
      Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Wyoming
      Casper,  Wyoming,  82601,  United States; Recruiting
      Casper,  Wyoming,  82604,  United States; Terminated
Canada, Ontario
      Kingston,  Ontario,  K7L5P9,  Canada; Not yet recruiting

Study ID Numbers:  104864/615
Record last reviewed:  October 2004
Record first received:  July 17, 2003
ClinicalTrials.gov Identifier:  NCT00065182
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10