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Phase 4
18 Years
N/A
Not Enrolling
Both
Neoplasms, Diarrhea

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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:

Interventional

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

Authority:

United States: Food and Drug Administration

Study ID:

CSMS995AUS38

NCT ID:

NCT00050635

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

Name

Location

Genesys Hurley Cancer InstituteFlint, Michigan  48503
California Cancer Care, Inc.Greenbrae, California  94904-2007
Oncology Services of AberdeenAberdeen, South Dakota  57401
North Coast Cancer Care, Inc.Sandusky, Ohio  44870
Missouri Cancer AssociatesColumbia, Missouri  65201
Cancer Care CenterNew Albany, Indiana  47150
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Oncology & Hematology Associates of West BrowardTamarac, Florida  33321
Kenmar Research InstituteLos Angeles, California  90057
Suniti Medical CorporationMerrillville, Indiana  46410
Oncology Hematology Group of South FloridaMiami, Florida  33176
Bay Area Cancer Research GroupConcord, California  94520
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
Pacific Shores Medical CenterLong Beach, California  90813
Pasco Hernando Oncology AssociatesNew Port Richey, Florida  34652
Mid-Florida Hematology & Oncology Centers, PAOrange City, Florida  32763
Creticos Cancer CenterChicago, Illinois  60657
Decatur Memorial HospitalDecatur, Illinois  62526
Cancer & Hematology Centers of Western MichiganGrand Rapids, Michigan  49546
Delta OncologyGreenwood, Mississippi  38930
Heartland Hematology Oncology AssociatesKansas City, Missouri  64118
Arch Medical Services/The Center for Cancer Care and ResearchSt. Louis, Missouri  63141
North Shore Hematology OncologyE. Setauket, New York  11733
Raleigh Hematology Oncology Associates, Wake PracticeRaleigh, North Carolina  27609
Dakota Clinic/Odyssey Research ServicesFargo, North Dakota  58103
Nashat Y. Gabrail, MDCanton, Ohio  44718
Lawrence M. Stallings, MDWooster, Ohio  44691
Consultants in Medical Oncology-HematologyDrexel Hill, Pennsylvania  19026
Regional Hematology Oncology AssocLanghorne, Pennsylvania  19047
Jones Oncolgy/Hematology ClinicGermantown, Tennessee  38138
McFaddin Ward Cancer - TOPABeaumont, Texas  77702
Scott & White Hospital/CCPCWaco, Texas  76702
Oncology & Hematology Associates of SW VARoanoke, Virginia  24014