Back to resultsComparing 3 Schedules of Alimta Plus Gemzar
Primary Purpose
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Lung cancer, cancer, neoplasm, non-small, chemotherapy
Eligibility Criteria
Inclusion Criteria: Diagnosis of non-small lung cancer No prior chemotherapy Able to care for self Exclusion Criteria: An ongoing infection Pregnancy or breast feeding Other serious medical condition Cancer that has spread to the brain Inability to take folic acid
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00034606
Brief Title
Comparing 3 Schedules of Alimta Plus Gemzar
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
Keywords
Lung cancer, cancer, neoplasm, non-small, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of non-small lung cancer
No prior chemotherapy
Able to care for self
Exclusion Criteria:
An ongoing infection
Pregnancy or breast feeding
Other serious medical condition
Cancer that has spread to the brain
Inability to take folic acid
Facility Information:
City
Rochester
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing 3 Schedules of Alimta Plus Gemzar
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