Comparing 3 Schedules of Alimta Plus Gemzar

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00034606
Collaborator
(none)
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rochester Minnesota United States

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00034606
    Other Study ID Numbers:
    • 5115
    • H3E-MC-JMEL
    First Posted:
    May 2, 2002
    Last Update Posted:
    Jul 19, 2006
    Last Verified:
    Jul 1, 2006

    Study Results

    No Results Posted as of Jul 19, 2006