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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Collaborator: |
Quintiles |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00050635 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Neoplasms Diarrhea |
Drug: Sandostatin LAR Depot |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion criteria:
Key Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| Compassionate Cancer Care medical Group, Inc. | |
| Fountain Valley, California, United States, 92708 | |
| Kenmar Research Institute | |
| Los Angeles, California, United States, 90057 | |
| Kenmar Research Institute | |
| Burbank, California, United States, 91505 | |
| Bay Area Cancer Research Group | |
| Concord, California, United States, 94520 | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904-2007 | |
| Pacific Shores Medical Center | |
| Long Beach, California, United States, 90813 | |
| United States, Florida | |
| Oncology Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| Pasco Hernando Oncology Associates | |
| New Port Richey, Florida, United States, 34652 | |
| Mid-Florida Hematology & Oncology Centers, PA | |
| Orange City, Florida, United States, 32763 | |
| Oncology & Hematology Associates of West Broward | |
| Tamarac, Florida, United States, 33321 | |
| United States, Illinois | |
| Creticos Cancer Center | |
| Chicago, Illinois, United States, 60657 | |
| Decatur Memorial Hospital | |
| Decatur, Illinois, United States, 62526 | |
| United States, Indiana | |
| Suniti Medical Corporation | |
| Merrillville, Indiana, United States, 46410 | |
| Cancer Care Center | |
| Bloomington, Indiana, United States, 47403 | |
| United States, Michigan | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Cancer & Hematology Centers of Western Michigan | |
| Grand Rapids, Michigan, United States, 49546 | |
| United States, Mississippi | |
| Delta Oncology | |
| Greenwood, Mississippi, United States, 38930 | |
| United States, Missouri | |
| Missouri Cancer Associates | |
| Columbia, Missouri, United States, 65201 | |
| Heartland Hematology Oncology Associates | |
| Kansas City, Missouri, United States, 64118 | |
| Arch Medical Services/The Center for Cancer Care and Research | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Mexico | |
| New Mexico Cancer Care Associates | |
| Santa Fe, New Mexico, United States, 87505 | |
| United States, New York | |
| North Shore Hematology Oncology | |
| E. Setauket, New York, United States, 11733 | |
| United States, North Carolina | |
| Raleigh Hematology Oncology Associates, Wake Practice | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, North Dakota | |
| Dakota Clinic/Odyssey Research Services | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Lawrence M. Stallings, MD | |
| Wooster, Ohio, United States, 44691 | |
| North Coast Cancer Care, Inc. | |
| Sandusky, Ohio, United States, 44870 | |
| Nashat Y. Gabrail, MD | |
| Canton, Ohio, United States, 44718 | |
| United States, Pennsylvania | |
| Consultants in Medical Oncology-Hematology | |
| Drexel Hill, Pennsylvania, United States, 19026 | |
| Regional Hematology Oncology Assoc | |
| Langhorne, Pennsylvania, United States, 19047 | |
| United States, South Dakota | |
| Oncology Services of Aberdeen | |
| Borden, South Dakota, United States, 57401 | |
| United States, Tennessee | |
| Jones Oncolgy/Hematology Clinic | |
| Germantown, Tennessee, United States, 38138 | |
| United States, Texas | |
| McFaddin Ward Cancer - TOPA | |
| Beaumont, Texas, United States, 77702 | |
| Scott & White Hospital/CCPC | |
| Waco, Texas, United States, 76702 | |
| United States, Virginia | |
| Oncology & Hematology Associates of SW VA | |
| Roanoke, Virginia, United States, 24014 | |
More Information
| Study ID Numbers: | CSMS995AUS38, STOP Trial |
| Study First Received: | December 17, 2002 |
| Last Updated: | November 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00050635 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
chemotherapy induced diarrhea diarrhea CTID colorectal cancer Sandostatin LAR Depot |
Sandostatin chemotherapy induced diarrhea adverse events side effects |
|
Signs and Symptoms Neoplasms Diarrhea Antineoplastic Agents, Hormonal Signs and Symptoms, Digestive |
Antineoplastic Agents Therapeutic Uses Gastrointestinal Agents Octreotide Pharmacologic Actions |
