The purposes of this study are to determine: 1) The safety of ALIMTA plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2) Whether ALIMTA plus Gemcitabine can help patients with mesothelioma live longer. 3) Whether ALIMTA plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4) To see if patients feel better while taking ALIMTA plus Gemcitabine.

Condition	Treatment or Intervention	Phase
Mesothelioma	Drug: ALIMTA Plus Gemcitabine	Phase II

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

Criteria

Inclusion Criteria:

• Diagnosis of mesothelioma that can be treated with chemotherapy
• Have received no prior chemotherapy for mesothelioma
• Have at least one measurable lesion
• Have an adequate performance status
• Sign an informed consent

Exclusion Criteria:

• Previous treatment with chemotherapy for mesothelioma
• Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating ALIMTA
• Treatment with radiation therapy within the last 4 weeks
• Brain metastasis that is uncontrolled
• Active infection or other serious condition

There may be multiple sites in this clinical trial      1-877-CTLILLY(1-877-285-4559) 

Colorado
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Denver,  Colorado,  United States; Recruiting
Florida
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Tampa,  Florida,  United States; Recruiting
Illinois
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Chicago,  Illinois,  United States; Recruiting
Maryland
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Baltimore,  Maryland,  United States; Recruiting
Massachusetts
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Boston,  Massachusetts,  United States; Recruiting
Michigan
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Ann Arbor,  Michigan,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Detroit,  Michigan,  United States; Recruiting
New Mexico
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Albuquerque,  New Mexico,  United States; Recruiting
New York
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., New York,  New York,  United States; Recruiting
Ohio
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Cleveland,  Ohio,  United States; Recruiting
Pennsylvania
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Philadelphia,  Pennsylvania,  United States; Recruiting
Wisconsin
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Madison,  Wisconsin,  United States; Recruiting

Study ID Numbers:  7214
Record last reviewed:  February 2004
Record first received:  May 28, 2003
ClinicalTrials.gov Identifier:  NCT00061477
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09