Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-03-20 @ 7:34 AM
Study NCT ID:
NCT00050635
Status:
COMPLETED
Last Update Posted:
2009-11-19
First Post:
2002-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2003-07'}, 'lastUpdateSubmitDate': '2009-11-18', 'studyFirstSubmitDate': '2002-12-17', 'studyFirstSubmitQcDate': '2002-12-17', 'lastUpdatePostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy'}]}, 'conditionsModule': {'keywords': ['chemotherapy induced diarrhea', 'diarrhea', 'CTID', 'colorectal cancer', 'Sandostatin LAR Depot', 'Sandostatin', 'adverse events', 'side effects'], 'conditions': ['Neoplasms', 'Diarrhea']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion criteria:\n\n* 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,\n* 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\n\nKey Exclusion criteria:\n\n* females who are pregnant or lactating,\n* current use of anticoagulants, except for those who are receiving 1 mg/per day of Coumadin for port maintenance,\n* known hypersensitivity to Sandostatin, Sandostatin LAR ® Depot or other related drug or compound,\n* history or presence of Crohn™s disease, ulcerative colitis, sprue, or known C. difficile infection, or any other diarrheal syndrome,\n* WBC \\< 3000 /L, Platelets \\< 75,000 /L, serum creatinine \\>2.0 mg/dL'}, 'identificationModule': {'nctId': 'NCT00050635', 'briefTitle': 'STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'orgStudyIdInfo': {'id': 'CSMS995AUS38'}, 'secondaryIdInfos': [{'id': 'STOP Trial'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Sandostatin LAR Depot', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Kenmar Research Institute', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Cancer Research Group', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Cancer Care medical Group, Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '94904-2007', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Care, Inc.', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Shores Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kenmar Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Oncology Hematology Group of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Pasco Hernando Oncology Associates', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Mid-Florida Hematology & Oncology Centers, PA', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Oncology & Hematology Associates of West Broward', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Creticos Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Decatur Memorial Hospital', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '47403', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Cancer Care Center', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '46410', 'city': 'Merrillville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Suniti Medical Corporation', 'geoPoint': {'lat': 41.48281, 'lon': -87.33281}}, {'zip': '48503', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Genesys Hurley Cancer Institute', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cancer & Hematology Centers of Western Michigan', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '38930', 'city': 'Greenwood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Delta Oncology', 'geoPoint': {'lat': 33.51623, 'lon': -90.17953}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Cancer Associates', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '64118', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Heartland Hematology Oncology Associates', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Arch Medical Services/The Center for Cancer Care and Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87505', 'city': 'Santa Fe', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico Cancer Care Associates', 'geoPoint': {'lat': 35.68698, 'lon': -105.9378}}, {'zip': '11733', 'city': 'East Setauket', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Hematology Oncology', 'geoPoint': {'lat': 40.94149, 'lon': -73.10594}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Hematology Oncology Associates, Wake Practice', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Dakota Clinic/Odyssey Research Services', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Nashat Y. Gabrail, MD', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44870', 'city': 'Sandusky', 'state': 'Ohio', 'country': 'United States', 'facility': 'North Coast Cancer Care, Inc.', 'geoPoint': {'lat': 41.44894, 'lon': -82.70796}}, {'zip': '44691', 'city': 'Wooster', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lawrence M. Stallings, MD', 'geoPoint': {'lat': 40.80517, 'lon': -81.93646}}, {'zip': '19026', 'city': 'Drexel Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Consultants in Medical Oncology-Hematology', 'geoPoint': {'lat': 39.94706, 'lon': -75.29213}}, {'zip': '19047', 'city': 'Langhorne', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Regional Hematology Oncology Assoc', 'geoPoint': {'lat': 40.17455, 'lon': -74.92267}}, {'zip': '57401', 'city': 'Borden', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Oncology Services of Aberdeen'}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Jones Oncolgy/Hematology Clinic', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '77702', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'McFaddin Ward Cancer - TOPA', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '76702', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott & White Hospital/CCPC', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Oncology & Hematology Associates of SW VA', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}]}}}