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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:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034619
First received: May 1, 2002
Last updated: July 18, 2006
Last verified: July 2006
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

  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
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Pittsfield, Massachusetts, United States
United States, Michigan
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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

No publications provided

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

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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013