ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00061464
  Purpose

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.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: pemetrexed
Drug: gemcitabine
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine    Pemetrexed disodium    Pemetrexed   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase II Clinical Trial

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To determine the tumor response rate for pemetrexed plus gemcitabine in patients with locally advanced or metastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC).

Secondary Outcome Measures:
  • To measure time-to-event efficacy variables including:
  • time to objective tumor response for responding patients
  • duration of response for responding patients
  • time to treatment failure
  • time to progressive disease
  • progression-free survival
  • overall survival
  • To characterize the quantitative and qualitative toxicities of pemetrexed plus gemcitabine in this patient population.

Estimated Enrollment:   48
Study Start Date:   February 2003
Estimated Study Completion Date:   February 2006

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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 1-2 weeks
  • Brain metastasis that is uncontrolled
  • Active infection or other serious condition
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061464

Locations
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Miami, Florida, United States
United States, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Chicago, Illinois, United States
United States, Louisiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Shreveport, Louisiana, United States
United States, South Carolina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Columbia, South Carolina, United States

Sponsors and Collaborators
Eli Lilly and Company

Investigators
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    
  More Information

Study ID Numbers:   7211, H3E-US-JMFX
First Received:   May 28, 2003
Last Updated:   January 24, 2007
ClinicalTrials.gov Identifier:   NCT00061464
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2008




Links to all studies - primarily for crawlers