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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00034619
Recruitment Status : Completed
First Posted : May 2, 2002
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: ALIMTA Drug: Oxaliplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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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 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
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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): NCT00034619


Locations
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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
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Latham, New York, United States
United States, North Carolina
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Asheville, North Carolina, United States
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Goldsboro, North Carolina, United States
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Hendersonville, North Carolina, United States
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Winston-Salem, North Carolina, United States
United States, Ohio
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Columbus, Ohio, United States
United States, Oregon
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Bend, Oregon, United States
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Portland, Oregon, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Reading, Pennsylvania, United States
United States, South Carolina
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Charleston, South Carolina, United States
United States, Utah
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Ivins, Utah, United States
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Ogden, Utah, United States
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Provo, Utah, United States
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St. George, Utah, United States
United States, Washington
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
Sponsors and Collaborators
Eli Lilly and Company
More Information
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ClinicalTrials.gov Identifier: NCT00034619    
Other Study ID Numbers: 5142
H3E-MC-JMEP
First Posted: May 2, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Oxaliplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors