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

Primary Purpose

Neoplasms, Diarrhea

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sandostatin LAR Depot
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms focused on measuring chemotherapy induced diarrhea, diarrhea, CTID, colorectal cancer, Sandostatin LAR Depot, Sandostatin, adverse events, side effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kenmar Research Institute
  • Bay Area Cancer Research Group
  • Compassionate Cancer Care medical Group, Inc.
  • California Cancer Care, Inc.
  • Pacific Shores Medical Center
  • Kenmar Research Institute
  • Oncology Hematology Group of South Florida
  • Pasco Hernando Oncology Associates
  • Mid-Florida Hematology & Oncology Centers, PA
  • Oncology & Hematology Associates of West Broward
  • Creticos Cancer Center
  • Decatur Memorial Hospital
  • Cancer Care Center
  • Suniti Medical Corporation
  • Genesys Hurley Cancer Institute
  • Cancer & Hematology Centers of Western Michigan
  • Delta Oncology
  • Missouri Cancer Associates
  • Heartland Hematology Oncology Associates
  • Arch Medical Services/The Center for Cancer Care and Research
  • New Mexico Cancer Care Associates
  • North Shore Hematology Oncology
  • Raleigh Hematology Oncology Associates, Wake Practice
  • Dakota Clinic/Odyssey Research Services
  • Nashat Y. Gabrail, MD
  • North Coast Cancer Care, Inc.
  • Lawrence M. Stallings, MD
  • Consultants in Medical Oncology-Hematology
  • Regional Hematology Oncology Assoc
  • Oncology Services of Aberdeen
  • Jones Oncolgy/Hematology Clinic
  • McFaddin Ward Cancer - TOPA
  • Scott & White Hospital/CCPC
  • Oncology & Hematology Associates of SW VA

Outcomes

Primary Outcome Measures

Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy

Secondary Outcome Measures

Full Information

First Posted
December 17, 2002
Last Updated
November 18, 2009
Sponsor
Novartis Pharmaceuticals
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00050635
Brief Title
STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Quintiles, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Diarrhea
Keywords
chemotherapy induced diarrhea, diarrhea, CTID, colorectal cancer, Sandostatin LAR Depot, Sandostatin, adverse events, side effects

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sandostatin LAR Depot
Primary Outcome Measure Information:
Title
Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kenmar Research Institute
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Bay Area Cancer Research Group
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Compassionate Cancer Care medical Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904-2007
Country
United States
Facility Name
Pacific Shores Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Kenmar Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Oncology Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Pasco Hernando Oncology Associates
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Mid-Florida Hematology & Oncology Centers, PA
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Oncology & Hematology Associates of West Broward
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Creticos Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Cancer Care Center
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Suniti Medical Corporation
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Cancer & Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Delta Oncology
City
Greenwood
State/Province
Mississippi
ZIP/Postal Code
38930
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Heartland Hematology Oncology Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
Arch Medical Services/The Center for Cancer Care and Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
New Mexico Cancer Care Associates
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
North Shore Hematology Oncology
City
E. Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Raleigh Hematology Oncology Associates, Wake Practice
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Dakota Clinic/Odyssey Research Services
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Nashat Y. Gabrail, MD
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
North Coast Cancer Care, Inc.
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Lawrence M. Stallings, MD
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Consultants in Medical Oncology-Hematology
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Regional Hematology Oncology Assoc
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Oncology Services of Aberdeen
City
Borden
State/Province
South Dakota
ZIP/Postal Code
57401
Country
United States
Facility Name
Jones Oncolgy/Hematology Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
McFaddin Ward Cancer - TOPA
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Scott & White Hospital/CCPC
City
Waco
State/Province
Texas
ZIP/Postal Code
76702
Country
United States
Facility Name
Oncology & Hematology Associates of SW VA
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States

12. IPD Sharing Statement

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

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