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ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00051493
Recruitment Status : Completed
First Posted : January 14, 2003
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 this study is to evaluate the effects (good and bad) of LY231514 (ALIMTA) and Carboplatin on you and your non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: ALIMTA Drug: Carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2002
Study Completion Date : December 2002

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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:

  • 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.
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): NCT00051493


Locations
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United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Eli Lilly and Company
More Information
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ClinicalTrials.gov Identifier: NCT00051493    
Other Study ID Numbers: 6142
H3E-MC-JMEZ
First Posted: January 14, 2003    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006
Keywords provided by Eli Lilly and Company:
Non-Small Cell Lung Cancer
Lung Cancer
NSCLC
Advanced Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Antineoplastic Agents