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Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00061451
First received: May 28, 2003
Last updated: December 20, 2010
Last verified: December 2010

May 28, 2003
December 20, 2010
December 2002
Not Provided
To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.
Not Provided
Complete list of historical versions of study NCT00061451 on ClinicalTrials.gov Archive Site
  • To assess time to objective tumor response for responding patients
  • To assess duration of response for responding patients
  • To assess time to treatment failure for patients
  • To assess progression free survival of patients
  • To assess time to progressive disease for patients
  • To assess survival time for patients
  • To characterize the toxicities of gemcitabine plus pemetrexed in this patient population
Not Provided
Not Provided
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Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial
ALIMTA Plus Gemcitabine as Front-line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Phase II Clinical Trial

The purposes of this study are to determine:

  1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
  2. Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.
  3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
  4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: Pemetrexed
  • Drug: Gemcitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2006
Not Provided

Inclusion Criteria:

  • Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy.
  • Have received no prior chemotherapy for Non-Small Cell Lung Cancer.
  • Have at least one measurable lesion.
  • Have an adequate performance status.
  • Sign an informed consent.

Exclusion Criteria:

  • A female who is pregnant or breastfeeding.
  • Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.
  • Treatment with radiation therapy within the last 4 weeks.
  • Brain metastasis that is uncontrolled.
  • Active infection or other serious condition.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00061451
7213, H3E-US-JMFY
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
December 2010

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