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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00071136
• Other study ID #: 7221
• Secondary ID: H3E-US-JMGC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 13, 2003
• Last updated: January 24, 2007
• Start date: December 2003
• Est. completion date: August 2006

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Drug:
• pemetrexed

• gemcitabine

Locations

Country	Name	City	State
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.	Dallas	Texas
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.	Ft. Myers	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.	Marshfield	Minnesota
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.	Minneapolis	Minnesota
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.	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	To measure the effects of chemotherapy treatment on:
Secondary	time until the cancer becomes less;time to cancer re-appears or becomes larger;length of time there is no increase in the amount of cancer;length of time patients survive;
Secondary	To measure the side-effects from this chemotherapy as given once every 14 days.