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

NCT ID: NCT00034619

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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ALIMTA

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"

Huntsville, Alabama, United States

Site Status

"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"

Pittsfield, Massachusetts, United States

Site Status

"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"

Kalamazoo, Michigan, United States

Site Status

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Latham, New York, United States

Site Status

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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

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Columbus, Ohio, United States

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Bend, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Charleston, South Carolina, United States

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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

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Bellevue, Washington, United States

Site Status

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Seattle, Washington, United States

Site Status

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Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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H3E-MC-JMEP

Identifier Type: -

Identifier Source: secondary_id

5142

Identifier Type: -

Identifier Source: org_study_id