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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.

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: January 10, 2003
Last updated: July 18, 2006
Last verified: July 2006
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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment: 50
Study Start Date: April 2002
Estimated Study Completion Date: December 2002

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00051493

United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Eli Lilly and Company
  More Information Identifier: NCT00051493     History of Changes
Other Study ID Numbers: 6142  H3E-MC-JMEZ 
Study First Received: January 10, 2003
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Non-Small Cell Lung Cancer
Lung Cancer
Advanced Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on January 18, 2017