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Comparing 3 Schedules of Alimta Plus Gemzar

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ClinicalTrials.gov Identifier: NCT00034606
Recruitment Status : Completed
First Posted : May 2, 2002
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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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
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms Drug: Pemetrexed (Alimta) in combination with gemcitabine (Gemzar) Phase 2

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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034606


Locations
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United States, Minnesota
Rochester, Minnesota, United States
Sponsors and Collaborators
Eli Lilly and Company
More Information
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ClinicalTrials.gov Identifier: NCT00034606    
Other Study ID Numbers: 5115
H3E-MC-JMEL
First Posted: May 2, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006
Keywords provided by Eli Lilly and Company:
Lung cancer
cancer
neoplasm
non-small
chemotherapy
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Pemetrexed
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors