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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.

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALIMTA
Oxaliplatin
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 1, 2002
Last Updated
July 18, 2006
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00034619
Brief Title
A Phase 2 Trial of ALIMTA (LY231514, Pemetrexed) Plus Oxaliplatin Administered Every 21 Days for First-Line Treatment of Patients With Advanced Colorectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ALIMTA
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Pittsfield
State/Province
Massachusetts
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Latham
State/Province
New York
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Goldsboro
State/Province
North Carolina
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Hendersonville
State/Province
North Carolina
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Bend
State/Province
Oregon
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Portland
State/Province
Oregon
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Reading
State/Province
Pennsylvania
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Ivins
State/Province
Utah
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Ogden
State/Province
Utah
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Provo
State/Province
Utah
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
St. George
State/Province
Utah
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Seattle
State/Province
Washington
Country
United States
Facility Name
"For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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