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Home > "S" Clinical Trials Conditions > STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
For Condition: Neoplasms,Diarrhea
Status: Completed
Sponsor(s): Novartis Pharmaceuticals , Quintiles
Synopsis: 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
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Key Inclusion criteria: - male or female patients of 18 years of age or older, scheduled or expected to receive at least two cycles of chemotherapy over at least a two- month period as primary or adjuvant therapy for any malignancy, - 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 Key Exclusion criteria: - females who are pregnant or lactating, - 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
Total Enrollment: 150
Location and Contact Information:
Oncology Services of Aberdeen
Borden, South Dakota, 57401
United States
North Shore Hematology Oncology
East Setauket, New York, 11733
United States
Pasco Hernando Oncology Associates
New Port Richey, Florida, 34652
United States
Heartland Hematology Oncology Associates
Kansas City, Missouri, 64118
United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505
United States
Oncology & Hematology Associates of West Broward
Tamarac, Florida, 33321
United States
Delta Oncology
Greenwood, Mississippi, 38930
United States
McFaddin Ward Cancer - TOPA
Beaumont, Texas, 77702
United States
Compassionate Cancer Care medical Group, Inc.
Fountain Valley, California, 92708
United States
California Cancer Care, Inc.
Greenbrae, California, 94904-2007
United States
Cancer Care Center
Bloomington, Indiana, 47403
United States
Arch Medical Services/The Center for Cancer Care and Research
St. Louis, Missouri, 63141
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Dakota Clinic/Odyssey Research Services
Fargo, North Dakota, 58103
United States
Bay Area Cancer Research Group
Concord, California, 94520
United States
Creticos Cancer Center
Chicago, Illinois, 60657
United States
North Coast Cancer Care, Inc.
Sandusky, Ohio, 44870
United States
Nashat Y. Gabrail, MD
Canton, Ohio, 44718
United States
Oncology & Hematology Associates of SW VA
Roanoke, Virginia, 24014
United States
Kenmar Research Institute
Los Angeles, California, 90057
United States
Suniti Medical Corporation
Merrillville, Indiana, 46410
United States
Lawrence M. Stallings, MD
Wooster, Ohio, 44691
United States
Regional Hematology Oncology Assoc
Langhorne, Pennsylvania, 19047
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Kenmar Research Institute
Burbank, California, 91505
United States
Oncology Hematology Group of South Florida
Miami, Florida, 33176
United States
Consultants in Medical Oncology-Hematology
Drexel Hill, Pennsylvania, 19026
United States
Scott & White Hospital/CCPC
Waco, Texas, 76702
United States
Mid-Florida Hematology & Oncology Centers, PA
Orange City, Florida, 32763
United States
Pacific Shores Medical Center
Long Beach, California, 90813
United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546
United States
Raleigh Hematology Oncology Associates, Wake Practice
Raleigh, North Carolina, 27609
United States
Jones Oncolgy/Hematology Clinic
Germantown, Tennessee, 38138
United States
Missouri Cancer Associates
Columbia, Missouri, 65201
United States
Additional Information:
Study ID Numbers: CSMS995AUS38; STOP Trial
Study Start Date: December 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050635
Other Neoplasms Studies:
1. Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
2. The Healthy Life Choices Project in HIV-Positive Patients
3. 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
4. A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea
5. Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
Related Studies:
Other Neoplasms Clinical Trials
Other Pennsylvania Clinical Trials
Other Drexel Hill Clinical Trials
STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
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