Back to resultsPemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Lung Neoplasms
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pemetrexed
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of advanced stage non-small cell lung cancer. Are able to be active at home and/or work. Have not received chemotherapy for this cancer disease. Have good organ function (for example, most blood work is normal). Have completed any prior radiation treatment at least 4 weeks ago. Exclusion Criteria: Have been treated with an investigational/research drug within the last month. Have cancer that has spread to the brain and is causing symptoms. Have an active infection or other serious medical condition. Have a second cancer in addition to non-small cell lung cancer. Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.
Sites / Locations
- 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.
- 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.
- 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.
- 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.
- 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.
Outcomes
Primary Outcome Measures
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 Outcome Measures
To measure the effects of chemotherapy treatment on:
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;
To measure the side-effects from this chemotherapy as given once every 14 days.
Full Information
NCT ID
NCT00071136
First Posted
October 13, 2003
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00071136
Brief Title
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title
Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To measure the effects of chemotherapy treatment on:
Title
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;
Title
To measure the side-effects from this chemotherapy as given once every 14 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of advanced stage non-small cell lung cancer.
Are able to be active at home and/or work.
Have not received chemotherapy for this cancer disease.
Have good organ function (for example, most blood work is normal).
Have completed any prior radiation treatment at least 4 weeks ago.
Exclusion Criteria:
Have been treated with an investigational/research drug within the last month.
Have cancer that has spread to the brain and is causing symptoms.
Have an active infection or other serious medical condition.
Have a second cancer in addition to non-small cell lung cancer.
Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Ft. Myers
State/Province
Florida
Country
United States
Facility Name
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.
City
Marshfield
State/Province
Minnesota
Country
United States
Facility Name
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.
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
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.
City
Rochester
State/Province
New York
Country
United States
Facility Name
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.
City
Dallas
State/Province
Texas
Country
United States
12. IPD Sharing Statement
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Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
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