A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer



Status:Terminated
Conditions:Colorectal Cancer, Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/2/2016
Start Date:June 2002

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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

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.


Other specific inclusion/exclusion criteria may apply. In order to determine eligibility,
further examination by the investigator is necessary.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
27
sites
Jacksonville, Florida 32207
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695 Charles E Young Drive South
Anaheim, California 92801
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Burlington, North Carolina 27216
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Burlington, NC
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Charleston, South Carolina 29403
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Concord, California 94520
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Dallas, Texas 75230
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East Lansing, Michigan 48824
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East Setauket, New York 11733
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Germantown, Tennessee 38138
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Gilroy, California 95020
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Gilroy, CA
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Greenville, North Carolina 27834
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226 Frogtown Road
Lancaster, Pennsylvania 17605
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Las Vegas, Nevada 89106
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Little Rock, Arkansas 72205
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Los Angeles, California 90057
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Madison, Wisconsin 53792
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4041 North Richards Street
Milwaukee, Wisconsin 53215
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Minneapolis, Minnesota 55455
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New Orleans, Louisiana 70115
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New Port Richey, Florida 34652
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Northport, New York 11768
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Philadelphia, Pennsylvania 19118
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Philadelphia, PA
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225 South Street
Pittsfield, Massachusetts 01201
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Scarborough, Maine 04074
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St. Joseph, Michigan 49085
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St. Joseph, Missouri 64507
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Zanesville, Ohio 43701
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Zanesville, OH
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