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

Condition	Treatment or Intervention	Phase
Neoplasms Diarrhea	Drug: Sandostatin LAR Depot	Phase IV

Further Study Details: 

Expected Total Enrollment:  150

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

California
      Compassionate Cancer Care medical Group, Inc., Fountain Valley,  California,  92708,  United States
      Kenmar Research Institute, Los Angeles,  California,  90057,  United States
      Kenmar Research Institute, Burbank,  California,  91505,  United States
      Bay Area Cancer Research Group, Concord,  California,  94520,  United States
      California Cancer Care, Inc., Greenbrae,  California,  94904-2007,  United States
      Pacific Shores Medical Center, Long Beach,  California,  90813,  United States
Florida
      Oncology Hematology Group of South Florida, Miami,  Florida,  33176,  United States
      Pasco Hernando Oncology Associates, New Port Richey,  Florida,  34652,  United States
      Mid-Florida Hematology & Oncology Centers, PA, Orange City,  Florida,  32763,  United States
      Oncology & Hematology Associates of West Broward, Tamarac,  Florida,  33321,  United States
Illinois
      Creticos Cancer Center, Chicago,  Illinois,  60657,  United States
      Decatur Memorial Hospital, Decatur,  Illinois,  62526,  United States
Indiana
      Suniti Medical Corporation, Merrillville,  Indiana,  46410,  United States
      Cancer Care Center, Bloomington,  Indiana,  47403,  United States
Michigan
      Genesys Hurley Cancer Institute, Flint,  Michigan,  48503,  United States
      Cancer & Hematology Centers of Western Michigan, Grand Rapids,  Michigan,  49546,  United States
Mississippi
      Delta Oncology, Greenwood,  Mississippi,  38930,  United States
Missouri
      Missouri Cancer Associates, Columbia,  Missouri,  65201,  United States
      Heartland Hematology Oncology Associates, Kansas City,  Missouri,  64118,  United States
      Arch Medical Services/The Center for Cancer Care and Research, St. Louis,  Missouri,  63141,  United States
New Mexico
      New Mexico Cancer Care Associates, Santa Fe,  New Mexico,  87505,  United States
New York
      North Shore Hematology Oncology, E. Setauket,  New York,  11733,  United States
North Carolina
      Raleigh Hematology Oncology Associates, Wake Practice, Raleigh,  North Carolina,  27609,  United States
North Dakota
      Dakota Clinic/Odyssey Research Services, Fargo,  North Dakota,  58103,  United States
Ohio
      Lawrence M. Stallings, MD, Wooster,  Ohio,  44691,  United States
      North Coast Cancer Care, Inc., Sandusky,  Ohio,  44870,  United States
      Nashat Y. Gabrail, MD, Canton,  Ohio,  44718,  United States
Pennsylvania
      Consultants in Medical Oncology-Hematology, Drexel Hill,  Pennsylvania,  19026,  United States
      Regional Hematology Oncology Assoc, Langhorne,  Pennsylvania,  19047,  United States
South Dakota
      Oncology Services of Aberdeen, Borden,  South Dakota,  57401,  United States
Tennessee
      Jones Oncolgy/Hematology Clinic, Germantown,  Tennessee,  38138,  United States
Texas
      McFaddin Ward Cancer - TOPA, Beaumont,  Texas,  77702,  United States
      Scott & White Hospital/CCPC, Waco,  Texas,  76702,  United States
Virginia
      Oncology & Hematology Associates of SW VA, Roanoke,  Virginia,  24014,  United States

Study ID Numbers:  CSMS995AUS38; STOP Trial
Record last reviewed:  March 2005
Last Updated:  March 18, 2005
Record first received:  December 17, 2002
ClinicalTrials.gov Identifier:  NCT00050635
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08