Purpose of study is to determine how effective and safe a new investigational drug is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.

Condition	Treatment or Intervention	Phase
Non-small cell lung cancer	Drug: Investigational Cancer Drug	Phase II

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

Criteria

Inclusion Criteria:

• Must have received only one prior platinum-based chemotherapy regimen.
• Blood tests will be done to check if blood counts are adequate for taking part in the study.

Exclusion Criteria:

• Received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function.
• Females who are pregnant.
• Any unstable, pre-existing major medical condition or history of other cancers.
• Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.

Arizona
      Scottsdale,  Arizona,  85259,  United States; Recruiting
Florida
      Jacksonville,  Florida,  32224-3899,  United States; Recruiting
Minnesota
      Rochester,  Minnesota,  55905,  United States; Recruiting
North Carolina
      Greensboro,  North Carolina,  27403-1199,  United States; Recruiting
Pennsylvania
      Philadelphia,  Pennsylvania,  19111,  United States; Recruiting

Study ID Numbers:  KSP20007
Record last reviewed:  October 2004
Record first received:  June 14, 2004
ClinicalTrials.gov Identifier:  NCT00085813
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29