- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00051493
ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.
July 18, 2006 updated by: Eli Lilly and Company
The purpose of this study is to evaluate the effects (good and bad) of LY231514 (ALIMTA) and Carboplatin on you and your non-small cell lung cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- You have a diagnosis of non-small cell lung cancer.
- You have received no prior chemotherapy.
- You have at least one measurable lesion.
- You have an adequate performance status.
- You are at least 18 years of age.
Exclusion Criteria:
- You have previously received chemotherapy for your lung cancer.
- You have received radiation within the last 30 days.
- You have active infection or other serious condition.
- You have brain metastasis.
- You have recently lost a significant amount of weight.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Completion
December 1, 2002
Study Registration Dates
First Submitted
January 10, 2003
First Submitted That Met QC Criteria
January 13, 2003
First Posted (Estimate)
January 14, 2003
Study Record Updates
Last Update Posted (Estimate)
July 19, 2006
Last Update Submitted That Met QC Criteria
July 18, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6142
- H3E-MC-JMEZ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.