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
About this trial
This is an interventional treatment trial for Colorectal Cancer
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
Sites / Locations
- "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)"
- "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)"
- "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)"
- "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)"
- "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)"
- "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)"
- "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)"
- "For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)"
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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City
Bend
State/Province
Oregon
Country
United States
Facility Name
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City
Portland
State/Province
Oregon
Country
United States
Facility Name
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City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
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City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
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City
Reading
State/Province
Pennsylvania
Country
United States
Facility Name
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City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
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City
Ivins
State/Province
Utah
Country
United States
Facility Name
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City
Ogden
State/Province
Utah
Country
United States
Facility Name
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City
Provo
State/Province
Utah
Country
United States
Facility Name
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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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