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Comparing 3 Schedules of Alimta Plus Gemzar

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034606
First received: May 1, 2002
Last updated: July 18, 2006
Last verified: July 2006
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034606

Locations
United States, Minnesota
Rochester, Minnesota, United States
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00034606     History of Changes
Other Study ID Numbers: 5115, H3E-MC-JMEL
Study First Received: May 1, 2002
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Lung cancer
cancer
neoplasm
non-small
chemotherapy

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on May 19, 2013