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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 Crohnâ„¢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

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