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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

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ClinicalTrials.gov Identifier: NCT00061451
Recruitment Status : Completed
First Posted : May 29, 2003
Last Update Posted : December 22, 2010
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 : December 2002
Actual Study Completion Date : September 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.

Secondary Outcome Measures :
  1. To assess time to objective tumor response for responding patients
  2. To assess duration of response for responding patients
  3. To assess time to treatment failure for patients
  4. To assess progression free survival of patients
  5. To assess time to progressive disease for patients
  6. To assess survival time for patients
  7. To characterize the toxicities of gemcitabine plus pemetrexed 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 4 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): NCT00061451


Locations
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United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Palo Alto, California, United States
United States, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 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, Missouri, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kansas City, Missouri, United States
United States, Montana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Great Falls, Montana, United States
United States, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seattle, Washington, 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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Additional Information:

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ClinicalTrials.gov Identifier: NCT00061451    
Other Study ID Numbers: 7213
H3E-US-JMFY
First Posted: May 29, 2003    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: December 2010
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