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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034619
First Posted: May 2, 2002
Last Update Posted: July 19, 2006
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.
Information provided by:
Eli Lilly and Company
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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)"
Asheville, 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)"
Hendersonville, North Carolina, United States
"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
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)"
Bend, Oregon, United States
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Portland, Oregon, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
"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
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
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
Bellevue, Washington, United States
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
Seattle, Washington, United States
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Spokane, Washington, United States
Sponsors and Collaborators
Eli Lilly and Company
  More Information

ClinicalTrials.gov Identifier: NCT00034619     History of Changes
Other Study ID Numbers: 5142
H3E-MC-JMEP
First Submitted: May 1, 2002
First Posted: May 2, 2002
Last Update Posted: July 19, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
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