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ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.

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: NCT00051506
Recruitment Status : Completed
First Posted : January 14, 2003
Last Update Posted : July 20, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE January 10, 2003
First Posted Date  ICMJE January 14, 2003
Last Update Posted Date July 20, 2006
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Lung Neoplasms
Intervention  ICMJE
  • Drug: ALIMTA
  • Drug: carboplatin
  • Drug: cisplatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of extensive stage small cell lung cancer and can be treated with chemotherapy.
  • Have received no prior chemotherapy for your disease.
  • Have at least one measurable lesion.
  • have an adequate performance status.
  • Sign an informed consent form.

Exclusion Criteria:

  • Have previously received chemotherapy for your lung cancer.
  • Have been treated with a investigational drug within the last 30 days. Have previously completed or withdrawn from this study or any other study investigating ALIMTA.
  • Have received radiation therapy within the last 1-2 weeks.
  • Have brain metastasis that is uncontrolled.
  • Have active infection or other serious condition.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00051506
Other Study ID Numbers  ICMJE 7210
H3E-US-JMFW
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eli Lilly and Company
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP