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

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:

MedlinePlus related topics: Colorectal Cancer

Drug Information available for: Oxaliplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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, see Learn About Clinical Studies.

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

Locations


United States, Alabama
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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


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 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016