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Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II, Phase I

Treatment

Completed

18 and over

Pharmaceutical / Industry

7221
H3E-US-JMGC, NCT00071136

Trial Description

Summary

This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. This treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. The primary goal is to find out if the tumor gets smaller or disappears with this treatment.

Eligibility Criteria

Inclusion Criteria:

1. Have a diagnosis of advanced stage non-small cell lung cancer.

2. Are able to be active at home and/or work.

3. Have not received chemotherapy for this cancer disease.

4. Have good organ function (for example, most blood work is normal).

5. Have completed any prior radiation treatment at least 4 weeks ago.

Exclusion Criteria:

1. Have been treated with an investigational/research drug within the last month.

2. Have cancer that has spread to the brain and is causing symptoms.

3. Have an active infection or other serious medical condition.

4. Have a second cancer in addition to non-small cell lung cancer.

5. Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.

Trial Contact Information

Trial Lead Organizations/Sponsors

Eli Lilly and Company

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00071136
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.