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Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.

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ClinicalTrials.gov Identifier: NCT00061464
Recruitment Status : Completed
First Posted : May 29, 2003
Last Update Posted : January 26, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: pemetrexed Drug: gemcitabine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2003
Study Completion Date : February 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. To measure time-to-event efficacy variables including:
  2. time to objective tumor response for responding patients
  3. duration of response for responding patients
  4. time to treatment failure
  5. time to progressive disease
  6. progression-free survival
  7. overall survival
  8. To characterize the quantitative and qualitative toxicities of pemetrexed plus gemcitabine in this patient population.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061464


Locations
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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
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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
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ClinicalTrials.gov Identifier: NCT00061464    
Other Study ID Numbers: 7211
H3E-US-JMFX
First Posted: May 29, 2003    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Pemetrexed
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors