STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
- Conditions
- NeoplasmsDiarrhea
- Registration Number
- NCT00050635
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Currently there is an ongoing clinical trial for patients with chemotherapy induced diarrhea. This trial is being conducted to evaluate the efficacy of two dose levels (30 mg and 40 mg) of an investigational drug in reducing the occurrence of severe (Grade 3 or 4) diarrhea during chemotherapy. Eligible patients must either have experienced NCI Common Toxicity Grade 1 - 4 chemotherapy-induced diarrhea during previous chemotherapy treatment or be experiencing Grade 1-4 chemotherapy-induced diarrhea currently.
In order to participate in this clinical trial, patients must be male or female 18 years of age or older. Inclusion into this investigational drug trial is based on the protocol entry criteria and a detailed evaluation from a participating trial investigator
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Creticos Cancer Center
🇺🇸Chicago, Illinois, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Oncology Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Dakota Clinic/Odyssey Research Services
🇺🇸Fargo, North Dakota, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Mid-Florida Hematology & Oncology Centers, PA
🇺🇸Orange City, Florida, United States
Pacific Shores Medical Center
🇺🇸Long Beach, California, United States
Suniti Medical Corporation
🇺🇸Merrillville, Indiana, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
North Shore Hematology Oncology
🇺🇸E. Setauket, New York, United States
Kenmar Research Institute
🇺🇸Los Angeles, California, United States
Compassionate Cancer Care medical Group, Inc.
🇺🇸Fountain Valley, California, United States
Cancer Care Center
🇺🇸Bloomington, Indiana, United States
Scott & White Hospital/CCPC
🇺🇸Waco, Texas, United States
Oncology & Hematology Associates of West Broward
🇺🇸Tamarac, Florida, United States
Raleigh Hematology Oncology Associates, Wake Practice
🇺🇸Raleigh, North Carolina, United States
Delta Oncology
🇺🇸Greenwood, Mississippi, United States
Jones Oncolgy/Hematology Clinic
🇺🇸Germantown, Tennessee, United States
Nashat Y. Gabrail, MD
🇺🇸Canton, Ohio, United States
Oncology Services of Aberdeen
🇺🇸Borden, South Dakota, United States
North Coast Cancer Care, Inc.
🇺🇸Sandusky, Ohio, United States
Arch Medical Services/The Center for Cancer Care and Research
🇺🇸St. Louis, Missouri, United States
Lawrence M. Stallings, MD
🇺🇸Wooster, Ohio, United States
Consultants in Medical Oncology-Hematology
🇺🇸Drexel Hill, Pennsylvania, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Bay Area Cancer Research Group
🇺🇸Concord, California, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
Heartland Hematology Oncology Associates
🇺🇸Kansas City, Missouri, United States
Pasco Hernando Oncology Associates
🇺🇸New Port Richey, Florida, United States
Cancer & Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Regional Hematology Oncology Assoc
🇺🇸Langhorne, Pennsylvania, United States
McFaddin Ward Cancer - TOPA
🇺🇸Beaumont, Texas, United States
Oncology & Hematology Associates of SW VA
🇺🇸Roanoke, Virginia, United States