Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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

Key facts

Study ID

NCT00061464

Run by

Eli Lilly and Company

People needed

48

Starts

2003-02-01

Expected to finish

2006-02-01

Last updated by the study team

2007-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy
• Have received no prior chemotherapy for Non-Small Cell Lung Cancer
• Have at least one measurable lesion
• Have an adequate performance status
• Sign an informed consent

You may not qualify if…

• A female who is pregnant or breastfeeding
• Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed
• Treatment with radiation therapy within the last 1-2 weeks
• Brain metastasis that is uncontrolled
• Active infection or other serious condition

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Miami, Florida, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Chicago, Illinois, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Shreveport, Louisiana, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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