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Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms

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Trial Information

Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To find out how often tumors become smaller or disappear in patients with advanced NSCLC treated with gemcitabine followed by pemetrexed once every 14 days. Chemotherapy treatment will be given for up to 12 times or until the cancer disease increases.

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

7221

NCT ID:

NCT00071136

Start Date:

December 2003

Completion Date:

August 2006

Related Keywords:

  • Lung Neoplasms
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
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. Ft. Myers, Florida  
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. Marshfield, Minnesota  
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. Rochester, New York  
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. Dallas, Texas