STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
NCT ID: NCT00050635
Last Updated: 2009-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2002-12-31
2003-07-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Sandostatin LAR Depot
Eligibility Criteria
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Inclusion Criteria
* have experienced NCI Common Toxicity Grade 1 - 4 diarrhea during previous chemotherapy treatment or are currently experiencing Grade 1-4 diarrhea due to chemotherapy treatment
Exclusion Criteria
* current use of anticoagulants, except for those who are receiving 1 mg/per day of Coumadin for port maintenance,
* known hypersensitivity to Sandostatin, Sandostatin LAR ® Depot or other related drug or compound,
* history or presence of Crohn™s disease, ulcerative colitis, sprue, or known C. difficile infection, or any other diarrheal syndrome,
* WBC \< 3000 /L, Platelets \< 75,000 /L, serum creatinine \>2.0 mg/dL
18 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Locations
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Kenmar Research Institute
Burbank, California, United States
Bay Area Cancer Research Group
Concord, California, United States
Compassionate Cancer Care medical Group, Inc.
Fountain Valley, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Pacific Shores Medical Center
Long Beach, California, United States
Kenmar Research Institute
Los Angeles, California, United States
Oncology Hematology Group of South Florida
Miami, Florida, United States
Pasco Hernando Oncology Associates
New Port Richey, Florida, United States
Mid-Florida Hematology & Oncology Centers, PA
Orange City, Florida, United States
Oncology & Hematology Associates of West Broward
Tamarac, Florida, United States
Creticos Cancer Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Cancer Care Center
Bloomington, Indiana, United States
Suniti Medical Corporation
Merrillville, Indiana, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Delta Oncology
Greenwood, Mississippi, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Heartland Hematology Oncology Associates
Kansas City, Missouri, United States
Arch Medical Services/The Center for Cancer Care and Research
St Louis, Missouri, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
North Shore Hematology Oncology
East Setauket, New York, United States
Raleigh Hematology Oncology Associates, Wake Practice
Raleigh, North Carolina, United States
Dakota Clinic/Odyssey Research Services
Fargo, North Dakota, United States
Nashat Y. Gabrail, MD
Canton, Ohio, United States
North Coast Cancer Care, Inc.
Sandusky, Ohio, United States
Lawrence M. Stallings, MD
Wooster, Ohio, United States
Consultants in Medical Oncology-Hematology
Drexel Hill, Pennsylvania, United States
Regional Hematology Oncology Assoc
Langhorne, Pennsylvania, United States
Oncology Services of Aberdeen
Borden, South Dakota, United States
Jones Oncolgy/Hematology Clinic
Germantown, Tennessee, United States
McFaddin Ward Cancer - TOPA
Beaumont, Texas, United States
Scott & White Hospital/CCPC
Waco, Texas, United States
Oncology & Hematology Associates of SW VA
Roanoke, Virginia, United States
Countries
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Other Identifiers
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STOP Trial
Identifier Type: -
Identifier Source: secondary_id
CSMS995AUS38
Identifier Type: -
Identifier Source: org_study_id