STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
2 other identifiers
interventional
150
1 country
34
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2002
Shorter than P25 for phase_4
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 17, 2002
CompletedFirst Posted
Study publicly available on registry
December 18, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedNovember 19, 2009
November 1, 2009
December 17, 2002
November 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- Quintiles, Inc.collaborator
Study Sites (34)
Kenmar Research Institute
Burbank, California, 91505, United States
Bay Area Cancer Research Group
Concord, California, 94520, United States
Compassionate Cancer Care medical Group, Inc.
Fountain Valley, California, 92708, United States
California Cancer Care, Inc.
Greenbrae, California, 94904-2007, United States
Pacific Shores Medical Center
Long Beach, California, 90813, United States
Kenmar Research Institute
Los Angeles, California, 90057, United States
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
Creticos Cancer Center
Chicago, Illinois, 60657, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Cancer Care Center
Bloomington, Indiana, 47403, United States
Suniti Medical Corporation
Merrillville, Indiana, 46410, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546, United States
Delta Oncology
Greenwood, Mississippi, 38930, United States
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 Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
North Shore Hematology Oncology
East Setauket, New York, 11733, United States
Raleigh Hematology Oncology Associates, Wake Practice
Raleigh, North Carolina, 27609, United States
Dakota Clinic/Odyssey Research Services
Fargo, North Dakota, 58103, United States
Nashat Y. Gabrail, MD
Canton, Ohio, 44718, United States
North Coast Cancer Care, Inc.
Sandusky, Ohio, 44870, United States
Lawrence M. Stallings, MD
Wooster, Ohio, 44691, United States
Consultants in Medical Oncology-Hematology
Drexel Hill, Pennsylvania, 19026, United States
Regional Hematology Oncology Assoc
Langhorne, Pennsylvania, 19047, United States
Oncology Services of Aberdeen
Borden, South Dakota, 57401, United States
Jones Oncolgy/Hematology Clinic
Germantown, Tennessee, 38138, United States
McFaddin Ward Cancer - TOPA
Beaumont, Texas, 77702, United States
Scott & White Hospital/CCPC
Waco, Texas, 76702, United States
Oncology & Hematology Associates of SW VA
Roanoke, Virginia, 24014, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 17, 2002
First Posted
December 18, 2002
Study Start
December 1, 2002
Study Completion
July 1, 2003
Last Updated
November 19, 2009
Record last verified: 2009-11