A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
NCT ID: NCT00040391
Last Updated: 2016-12-01
Study Results
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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TERMINATED
PHASE2
INTERVENTIONAL
2002-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Investigational drug
Irinotecan
5-fluorouracil
Leucovorin
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of colorectal cancer or adenocarcinoma of the appendix
* A tumor mass that can be measured
* Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1
* Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures
Exclusion Criteria
* Prior treatment with Irinotecan
* Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy or other major abdominal surgery that might result in substantial alteration in transit or absorption of oral medication
* Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization
* Current enrollment in another clinical trial
* Administration of any prior systemic anticancer therapy for metastatic colorectal cancer
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Celgene Corporation
INDUSTRY
Responsible Party
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Locations
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Research Center
Little Rock, Arkansas, United States
Research Center
Anaheim, California, United States
Research Center
Concord, California, United States
Research Center
Gilroy, California, United States
Research Center
Los Angeles, California, United States
Research Center
Jacksonville, Florida, United States
Research Center
New Port Richey, Florida, United States
Research Center
New Orleans, Louisiana, United States
Research Center
Scarborough, Maine, United States
Research Center
Pittsfield, Massachusetts, United States
Research Center
East Lansing, Michigan, United States
Research Center
Saint Joseph, Michigan, United States
Research Center
Minneapolis, Minnesota, United States
Research Center
Saint Joseph, Missouri, United States
Research Center
Las Vegas, Nevada, United States
Research Center
East Setauket, New York, United States
Research Center
Northport, New York, United States
Research Center
Burlington, North Carolina, United States
Research Center
Greenville, North Carolina, United States
Research Center
Zanesville, Ohio, United States
Research Center
Lancaster, Pennsylvania, United States
Research Center
Philadelphia, Pennsylvania, United States
Research Center
Charleston, South Carolina, United States
Research Center
Charleston, South Carolina, United States
Research Center
Germantown, Tennessee, United States
Research Center
Dallas, Texas, United States
Research Center
Madison, Wisconsin, United States
Research Center
Milwaukee, Wisconsin, United States
Countries
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References
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Pan CX, Loehrer P, Seitz D, Helft P, Juliar B, Ansari R, Pletcher W, Vinson J, Cheng L, Sweeney C. A phase II trial of irinotecan, 5-fluorouracil and leucovorin combined with celecoxib and glutamine as first-line therapy for advanced colorectal cancer. Oncology. 2005;69(1):63-70. doi: 10.1159/000087302. Epub 2005 Aug 2.
Other Identifiers
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440E-ONC-0020-315
Identifier Type: -
Identifier Source: org_study_id