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

July 18, 2006 updated by: Eli Lilly and Company

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

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Intervention / Treatment

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Huntsville, Alabama, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- Massachusetts
  - Pittsfield, Massachusetts, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- Michigan
  - Kalamazoo, Michigan, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- New York
  - Latham, New York, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- North Carolina
  - 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
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- Ohio
  - Columbus, Ohio, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- Oregon
  - Bend, Oregon, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
  - Portland, Oregon, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- Pennsylvania
  - 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
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- South Carolina
  - Charleston, South Carolina, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- Utah
  - Ivins, Utah, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
  - Ogden, Utah, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
  - Provo, Utah, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
  - St. George, Utah, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
- Washington
  - 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
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
  - Spokane, Washington, United States
    - "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 1, 2002

First Submitted That Met QC Criteria

May 1, 2002

First Posted (Estimate)

May 2, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

5142
H3E-MC-JMEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.