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Phase 4
18 Years
Not Enrolling
Neoplasms, Diarrhea

Thank you

Trial Information

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy


United States: Food and Drug Administration

Study ID:




Start Date:

December 2002

Completion Date:

July 2003

Related Keywords:

  • Neoplasms
  • Diarrhea
  • chemotherapy induced diarrhea
  • diarrhea
  • CTID
  • colorectal cancer
  • Sandostatin LAR Depot
  • Sandostatin
  • adverse events
  • side effects
  • Neoplasms
  • Diarrhea



Genesys Hurley Cancer Institute Flint, Michigan  48503
California Cancer Care, Inc. Greenbrae, California  94904-2007
Oncology Services of Aberdeen Aberdeen, South Dakota  57401
North Coast Cancer Care, Inc. Sandusky, Ohio  44870
Missouri Cancer Associates Columbia, Missouri  65201
Cancer Care Center New Albany, Indiana  47150
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Oncology & Hematology Associates of West Broward Tamarac, Florida  33321
Kenmar Research Institute Los Angeles, California  90057
Suniti Medical Corporation Merrillville, Indiana  46410
Oncology Hematology Group of South Florida Miami, Florida  33176
Bay Area Cancer Research Group Concord, California  94520
Compassionate Cancer Care medical Group, Inc. Fountain Valley, California  92708
Pacific Shores Medical Center Long Beach, California  90813
Pasco Hernando Oncology Associates New Port Richey, Florida  34652
Mid-Florida Hematology & Oncology Centers, PA Orange City, Florida  32763
Creticos Cancer Center Chicago, Illinois  60657
Decatur Memorial Hospital Decatur, Illinois  62526
Cancer & Hematology Centers of Western Michigan Grand Rapids, Michigan  49546
Delta Oncology Greenwood, Mississippi  38930
Heartland Hematology Oncology Associates Kansas City, Missouri  64118
Arch Medical Services/The Center for Cancer Care and Research St. Louis, Missouri  63141
North Shore Hematology Oncology E. Setauket, New York  11733
Raleigh Hematology Oncology Associates, Wake Practice Raleigh, North Carolina  27609
Dakota Clinic/Odyssey Research Services Fargo, North Dakota  58103
Nashat Y. Gabrail, MD Canton, Ohio  44718
Lawrence M. Stallings, MD Wooster, Ohio  44691
Consultants in Medical Oncology-Hematology Drexel Hill, Pennsylvania  19026
Regional Hematology Oncology Assoc Langhorne, Pennsylvania  19047
Jones Oncolgy/Hematology Clinic Germantown, Tennessee  38138
McFaddin Ward Cancer - TOPA Beaumont, Texas  77702
Scott & White Hospital/CCPC Waco, Texas  76702
Oncology & Hematology Associates of SW VA Roanoke, Virginia  24014