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

November 18, 2009 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Burbank, California, United States, 91505
        • Kenmar Research Institute
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Care Medical Group, Inc.
      • Greenbrae, California, United States, 94904-2007
        • California Cancer Care, Inc.
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Center
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
    • Florida
      • Miami, Florida, United States, 33176
        • Oncology Hematology Group of South Florida
      • New Port Richey, Florida, United States, 34652
        • Pasco Hernando Oncology Associates
      • Orange City, Florida, United States, 32763
        • Mid-Florida Hematology & Oncology Centers, PA
      • Tamarac, Florida, United States, 33321
        • Oncology & Hematology Associates of West Broward
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Creticos Cancer Center
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Cancer Care Center
      • Merrillville, Indiana, United States, 46410
        • Suniti Medical Corporation
    • Michigan
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, United States, 49546
        • Cancer & Hematology Centers of Western Michigan
    • Mississippi
      • Greenwood, Mississippi, United States, 38930
        • Delta Oncology
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology Oncology Associates
      • St. Louis, Missouri, United States, 63141
        • Arch Medical Services/The Center for Cancer Care and Research
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • New Mexico Cancer Care Associates
    • New York
      • E. Setauket, New York, United States, 11733
        • North Shore Hematology Oncology
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Raleigh Hematology Oncology Associates, Wake Practice
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Dakota Clinic/Odyssey Research Services
    • Ohio
      • Canton, Ohio, United States, 44718
        • Nashat Y. Gabrail, MD
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care, Inc.
      • Wooster, Ohio, United States, 44691
        • Lawrence M. Stallings, MD
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States, 19026
        • Consultants in Medical Oncology-Hematology
      • Langhorne, Pennsylvania, United States, 19047
        • Regional Hematology Oncology Assoc
    • South Dakota
      • Borden, South Dakota, United States, 57401
        • Oncology Services of Aberdeen
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Jones Oncolgy/Hematology Clinic
    • Texas
      • Beaumont, Texas, United States, 77702
        • McFaddin Ward Cancer - TOPA
      • Waco, Texas, United States, 76702
        • Scott & White Hospital/CCPC
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Oncology & Hematology Associates of SW VA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

Quintiles, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion

July 1, 2003

Study Registration Dates

First Submitted

December 17, 2002

First Submitted That Met QC Criteria

December 17, 2002

First Posted (Estimate)

December 18, 2002

Study Record Updates

Last Update Posted (Estimate)

November 19, 2009

Last Update Submitted That Met QC Criteria

November 18, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMS995AUS38
  • STOP Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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