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To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191191
First received: September 12, 2005
Last updated: December 4, 2009
Last verified: December 2009
History of Changes

September 12, 2005
December 4, 2009
October 2004
October 2008   (final data collection date for primary outcome measure)
Best Overall Response [ Time Frame: baseline to measured progressive disease (up to 3.2 years) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00191191 on ClinicalTrials.gov Archive Site
  • Duration of Response [ Time Frame: time of response to progressive disease (up to 3.2 years) ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease (up to 3.2 years) ] [ Designated as safety issue: No ]
  • Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) [ Time Frame: Baseline (pre-dose), 3 Months after first dose of Cycle 1 ] [ Designated as safety issue: No ]
  • Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS) [ Time Frame: Baseline (pre-dose), 3 Months after first dose of Cycle 1 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)
LY231514 500 mg/m2 and LY231514 1000 mg/m2 in Patients With Advanced Non-Small Cell Lung Cancer Who Were Previously Treated With Prior Systemic Anti Cancer Therapy: A Randomized Phase II Trial

To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Pemetrexed 500 mg/m2
    500 mg/m2, intravenous (IV), every 21 days, one year from registration date
    Other Names:
    • Alimta
    • LY231514
  • Drug: Pemetrexed 1000 mg/m2
    1000 mg/m2, intravenous (IV), every 21 days, one year from registration date
    Other Names:
    • Alimta
    • LY231514
  • Experimental: Pemetrexed 500 mg/m2
    Pemetrexed 500 mg/m2
    Intervention: Drug: Pemetrexed 500 mg/m2
  • Experimental: Pemetrexed 1000 mg/m2
    Pemetrexed 1000 mg/m2
    Intervention: Drug: Pemetrexed 1000 mg/m2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical stage III or IV
  • Previously treated with one or two chemotherapeutic regimens
  • Performance status: 0-2

Exclusion Criteria:

- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00191191
5250, H3E-JE-NS01
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time(UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
December 2009

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