Back to resultsALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALIMTA
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00051493
Brief Title
ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.
Official Title
ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ALIMTA
Intervention Type
Drug
Intervention Name(s)
Carboplatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.
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