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A Phase 2 Trial of ALIMTA (LY231514, Pemetrexed) Plus Oxaliplatin Administered Every 21 Days for First-Line Treatment of Patients With Advanced Colorectal Cancer.

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00034619
  Purpose

The purpose of this study is to assess the antitumor activity of ALIMTA plus Oxaliplatin combination therapy in patients with previously untreated advanced colorectal cancer


Condition Intervention Phase
Colorectal Cancer
 Drug: ALIMTA
Drug: Oxaliplatin
 Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

Drug Information available for:   Pemetrexed disodium    Pemetrexed    Oxaliplatin   

U.S. FDA Resources

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

Criteria

Inclusion Criteria:

  • Diagnosis of primary cancer of the colon or rectum
  • Must have measurable disease
  • Must be able to comply with study procedure

Exclusion Criteria:

  • Prior chemotherapy for advanced disease
  • Pregnancy or lactation
  • Candidates for surgical resection of one or more metastatic foci
  • Second primary cancer
  • Inability to take folic acid or vitamin B12
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034619

Locations
United States, Alabama
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Huntsville, Alabama, United States
United States, Massachusetts
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Pittsfield, Massachusetts, United States
United States, Michigan
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Kalamazoo, Michigan, United States
United States, New York
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Latham, New York, United States
United States, North Carolina
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Winston-Salem, North Carolina, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Goldsboro, North Carolina, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Asheville, North Carolina, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Hendersonville, North Carolina, United States
United States, Ohio
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Columbus, Ohio, United States
United States, Oregon
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Portland, Oregon, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Bend, Oregon, United States
United States, Pennsylvania
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Pittsburgh, Pennsylvania, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Reading, Pennsylvania, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Philadelphia, Pennsylvania, United States
United States, South Carolina
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Charleston, South Carolina, United States
United States, Utah
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Provo, Utah, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Ivins, Utah, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      St. George, Utah, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Ogden, Utah, United States
United States, Washington
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Seattle, Washington, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Spokane, Washington, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"    
      Bellevue, Washington, United States

Sponsors and Collaborators
Eli Lilly and Company
  More Information


Study ID Numbers:   5142, H3E-MC-JMEP
First Received:   May 1, 2002
Last Updated:   July 18, 2006
ClinicalTrials.gov Identifier:   NCT00034619
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

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