Clinical Studies
Cancer Therapy-Induced Diarrhea
Salient Pharmaceuticals is currently sponsoring a clinical study using all-natural CASAD™ to treat metastatic colorectal cancer patients receiving irinotecan® alone or in combination with other therapies. Salient has selected this trial as its first study because of the significant incidence of severe diarrhea associated with irinotecan treatment and the fact that diarrhea is the treatment regimen’s dose-limiting side effect. At this time there are no preventative medications to stop diarrhea from occurring and the available treatments may not be effective for many patients.
The clinical study is being conducted at the University of Texas MD Anderson Cancer Center and several other leading oncology clinics around the nation. If you are a colorectal cancer patient receiving or scheduled to receive irinotecan, you may be eligible for the trial if you are being treated at one of the sites listed below and you meet the study criteria. If the clinical study is available in your area and you believe you may qualify, please contact your doctor for more information.
You may qualify for the CASAD study if ALL these factors describe your condition:
- Patients with metastatic colorectal cancer to receive irinotecan alone or in combination with 5-FU, cetuximab or other biologics, including Avastin
- Patients receiving their first or second dose of irinotecan (unless there is a 4-week period since last dose)
- Over 18 years old
- Adequate organ function
- Adequate bone marrow function
- Negative urine pregnancy test for women of childbearing age
- Women of childbearing age and all men must agree to use adequate contraception prior to study entry and for the duration of study participation
- Ability to understand and willingness to provide a written, informed consent to participate in the study
- Brain metastasis must have been previously treated
Any of the following conditions would EXCLUDE you from participating:
- History of allergies to irinotecan
- Known history of Gilbert’s disease
- Patients with existing colostomy/ileostomy due to the difficulty in grading diarrhea
- Pregnancy or lactation
- History of significant neurological or psychiatric disorders that would impede giving consent, treatment or follow-up
- Any serious illness or medical condition, such as uncontrolled congestive heart failure, uncontrolled hypertension or arrhythmia, active angina pectoris or symptomatic heart disease
- Serious uncontrolled active infection
- Irinotecan treatment within last two weeks
- Concurrent radiation therapy
- Prior radiation therapy within 4 weeks of trial enrollment
Clinical Study Locations
ATLANTA, GA
Atlanta Regional Community Clinical Oncology Program, a Division of Saint Joseph's Hospital of Atlanta, Inc.
DECATUR, IL
Decatur Memorial Hospital
ALEXANDRIA, LA
Christus St. Frances Cabrini Hospital
KALAMAZOO, MI
West Michigan Cancer Center
SPRINGFIELD, MO
Ozark Health Ventures dba Cancer Research for the Ozarks (CoxHealth)
PORTLAND, OR
Columbia River Oncology Program
WYNNEWOOD, PA
Main Line Hospitals, Inc.
GREENVILLE, SC
Greenville Hospital System University Medical Center
SPARTENBURG, SC
Spartanburg Regional Medical Center
NASHVILLE, TN
Meharry Medical College
HOUSTON, TX
M.D. Anderson Cancer Center
TEMPLE, TX
Scott and White Hospital
Additional information on Salient Pharmaceuticals’ current clinical studies can also be found at:
