STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea

Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050635
• Other study ID #: CSMS995AUS38
• Secondary ID: STOP Trial
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2002
• Last updated: November 18, 2009
• Start date: December 2002
• Est. completion date: July 2003

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Neoplasms

Intervention

Drug:
• Sandostatin LAR Depot

Locations

Country	Name	City	State
United States	McFaddin Ward Cancer - TOPA	Beaumont	Texas
United States	Cancer Care Center	Bloomington	Indiana
United States	Oncology Services of Aberdeen	Borden	South Dakota
United States	Kenmar Research Institute	Burbank	California
United States	Nashat Y. Gabrail, MD	Canton	Ohio
United States	Creticos Cancer Center	Chicago	Illinois
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Bay Area Cancer Research Group	Concord	California
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Consultants in Medical Oncology-Hematology	Drexel Hill	Pennsylvania
United States	North Shore Hematology Oncology	E. Setauket	New York
United States	Dakota Clinic/Odyssey Research Services	Fargo	North Dakota
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Compassionate Cancer Care medical Group, Inc.	Fountain Valley	California
United States	Jones Oncolgy/Hematology Clinic	Germantown	Tennessee
United States	Cancer & Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	California Cancer Care, Inc.	Greenbrae	California
United States	Delta Oncology	Greenwood	Mississippi
United States	Heartland Hematology Oncology Associates	Kansas City	Missouri
United States	Regional Hematology Oncology Assoc	Langhorne	Pennsylvania
United States	Pacific Shores Medical Center	Long Beach	California
United States	Kenmar Research Institute	Los Angeles	California
United States	Suniti Medical Corporation	Merrillville	Indiana
United States	Oncology Hematology Group of South Florida	Miami	Florida
United States	Pasco Hernando Oncology Associates	New Port Richey	Florida
United States	Mid-Florida Hematology & Oncology Centers, PA	Orange City	Florida
United States	Raleigh Hematology Oncology Associates, Wake Practice	Raleigh	North Carolina
United States	Oncology & Hematology Associates of SW VA	Roanoke	Virginia
United States	North Coast Cancer Care, Inc.	Sandusky	Ohio
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Arch Medical Services/The Center for Cancer Care and Research	St. Louis	Missouri
United States	Oncology & Hematology Associates of West Broward	Tamarac	Florida
United States	Scott & White Hospital/CCPC	Waco	Texas
United States	Lawrence M. Stallings, MD	Wooster	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy