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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00050635
Recruitment Status : Completed
First Posted : December 18, 2002
Last Update Posted : November 19, 2009
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by:
Novartis

Study Description
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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


Condition or disease Intervention/treatment Phase
Neoplasms Diarrhea Drug: Sandostatin LAR Depot Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : December 2002
Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050635


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Quintiles, Inc.
More Information
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ClinicalTrials.gov Identifier: NCT00050635    
Other Study ID Numbers: CSMS995AUS38
STOP Trial
First Posted: December 18, 2002    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009
Keywords provided by Novartis:
chemotherapy induced diarrhea
diarrhea
CTID
colorectal cancer
 Sandostatin LAR Depot
Sandostatin
adverse events
side effects
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Octreotide
 Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents