This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with a platinum-containing chemotherapy regimen.

A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.

Condition	Treatment or Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: MAC-321	Phase II

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

Criteria

Inclusion Criteria:

A physician participating in the study will determine eligibility, but if you meet the following criteria, you may qualify for this study:

• Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen containing a platinum agent.
• Recovery from all acute side effects of prior therapies (with the exception of hair loss).
• Adequate bone marrow, liver, and kidney function

Exclusion Criteria:

• More than 2 prior chemotherapy regimens for treatment of advanced or metastatic non-small cell lung cancer. (Treatment given in conjunction with surgery will not be included in the maximum of 2 prior regimens).
• Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study.
• Symptomatic brain metastases.
• HIV, hepatitis B and/or hepatitis C infection.
• Serious health problems such as uncontrolled serious infections, disabling heart disease, or uncontrolled major seizure disorder.
• History of allergic reactions to docetaxel or paclitaxel.
• Prior exposure to MAC-321.

California
      University of Sourthern California, Norris Comprehensive Cancer Center, Los Angeles,  California,  90033,  United States; Recruiting
Florida
      H. Lee Moffitt Cancer Center, Tampa,  Florida,  33612,  United States; Recruiting
Kentucky
      Markey Cancer Center, Lexington,  Kentucky,  40536-0098,  United States; Recruiting
Maryland
      John Hopkins Hospital Oncology Center, Baltimore,  Maryland,  21231-1000,  United States; Recruiting
Massachusetts
      UMass Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States; Recruiting
Minnesota
      University of Minnesota, Department of Medicine/HOT, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Missouri
      Washington University, Siteman Cancer Center, St. Louis,  Missouri,  63110,  United States; Recruiting
New York
      Columbia University, New York,  New York,  10032,  United States; Recruiting
North Carolina
      Carolinas Hematology-Oncology Associates, Charlotte,  North Carolina,  28203,  United States; Recruiting
Ohio
      Cleveland Clinic, Cleveland,  Ohio,  44195,  United States; Recruiting
Pennsylvania
      Fox Chase/Temple Cancer Center, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Tennessee
      Vanderbilt University, Nashville,  Tennessee,  37232,  United States; Recruiting

Study ID Numbers:  3128K1-201-WW
Record last reviewed:  January 2005
Last Updated:  January 27, 2005
Record first received:  June 23, 2003
ClinicalTrials.gov Identifier:  NCT00063219
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08