A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
A Phase II, Randomized, Open-label, Controlled, Dose-elevation, Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer
1 other identifier
interventional
N/A
1 country
28
Brief Summary
The study will combine a new investigational drug with standard anti-cancer drugs for the treatment of advanced colorectal cancer. The standard and approved treatment for colorectal cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5-FU), and leucovorin (also known as LV). This is known as the triple therapy. One of the major side effects of CPT-11/5-FU/LV chemotherapy treatment is diarrhea. The purpose of this research study is to see whether adding this investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. This study will also determine if adding the investigational drug to triple therapy has a positive effect on tumors.
Trial Health
Trial Health Score
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28 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 26, 2002
CompletedFirst Posted
Study publicly available on registry
June 27, 2002
CompletedDecember 1, 2016
November 1, 2016
June 26, 2002
November 30, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
You may not qualify if:
- Age 18 years or older
- 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
- Women that are pregnant or lactating
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgene Corporationlead
- Pfizercollaborator
Study Sites (28)
Research Center
Little Rock, Arkansas, 72205, United States
Research Center
Anaheim, California, 92801, United States
Research Center
Concord, California, 94520, United States
Research Center
Gilroy, California, 95020, United States
Research Center
Los Angeles, California, 90057, United States
Research Center
Jacksonville, Florida, 32207, United States
Research Center
New Port Richey, Florida, 34652, United States
Research Center
New Orleans, Louisiana, 70115, United States
Research Center
Scarborough, Maine, 04074-9308, United States
Research Center
Pittsfield, Massachusetts, 01201, United States
Research Center
East Lansing, Michigan, 48824, United States
Research Center
Saint Joseph, Michigan, 49085, United States
Research Center
Minneapolis, Minnesota, 55455, United States
Research Center
Saint Joseph, Missouri, 64507, United States
Research Center
Las Vegas, Nevada, 89106, United States
Research Center
East Setauket, New York, 11733, United States
Research Center
Northport, New York, 11768-2364, United States
Research Center
Burlington, North Carolina, 27216, United States
Research Center
Greenville, North Carolina, 27834, United States
Research Center
Zanesville, Ohio, 43701, United States
Research Center
Lancaster, Pennsylvania, 17605, United States
Research Center
Philadelphia, Pennsylvania, 19140-5189, United States
Research Center
Charleston, South Carolina, 29403, United States
Research Center
Charleston, South Carolina, 29406, United States
Research Center
Germantown, Tennessee, 38138, United States
Research Center
Dallas, Texas, 75230, United States
Research Center
Madison, Wisconsin, 53792-2454, United States
Research Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (1)
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.
PMID: 16088234BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2002
First Posted
June 27, 2002
Study Start
June 1, 2002
Last Updated
December 1, 2016
Record last verified: 2016-11