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

Use our guide to learn which trials are right for you!

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
St. Joseph, Michigan 49085
?
mi
from
St. Joseph, MI
Click here to add this to my saved trials
695 Charles E Young Drive South
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Burlington, North Carolina 27216
?
mi
from
Burlington, NC
Click here to add this to my saved trials
Charleston, South Carolina 29403
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Concord, California 94520
?
mi
from
Concord, CA
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
East Lansing, Michigan 48824
?
mi
from
East Lansing, MI
Click here to add this to my saved trials
East Setauket, New York 11733
?
mi
from
East Setauket, NY
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Gilroy, California 95020
?
mi
from
Gilroy, CA
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
226 Frogtown Road
Lancaster, Pennsylvania 17605
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89106
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 90057
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
4041 North Richards Street
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New Orleans, Louisiana 70115
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Port Richey, Florida 34652
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
Northport, New York 11768
?
mi
from
Northport, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19118
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
225 South Street
Pittsfield, Massachusetts 01201
?
mi
from
Pittsfield, MA
Click here to add this to my saved trials
Scarborough, Maine 04074
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
St. Joseph, Missouri 64507
?
mi
from
St. Joseph, MO
Click here to add this to my saved trials
Zanesville, Ohio 43701
?
mi
from
Zanesville, OH
Click here to add this to my saved trials