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NeoplasmsPhase 4NCT00050635

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

A Phase 4 study testing Sandostatin LAR Depot in people with Neoplasms and Diarrhea, run by Novartis Pharmaceuticals at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Diarrhea
What is being tested?
Sandostatin LAR Depot
How many people
150 participants
Where
34 sitesUnited States
Study dates
Dec 2002to Jul 2003
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • McFaddin Ward Cancer - TOPA

    Beaumont, Texas, 77702

  • Cancer Care Center

    Bloomington, Indiana, 47403

  • Oncology Services of Aberdeen

    Borden, South Dakota, 57401

  • Kenmar Research Institute

    Burbank, California, 91505

  • Nashat Y. Gabrail, MD

    Canton, Ohio, 44718

  • Creticos Cancer Center

    Chicago, Illinois, 60657

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Bay Area Cancer Research Group

    Concord, California, 94520

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Consultants in Medical Oncology-Hematology

    Drexel Hill, Pennsylvania, 19026

  • North Shore Hematology Oncology

    East Setauket, New York, 11733

  • Dakota Clinic/Odyssey Research Services

    Fargo, North Dakota, 58103

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Compassionate Cancer Care medical Group, Inc.

    Fountain Valley, California, 92708

  • Jones Oncolgy/Hematology Clinic

    Germantown, Tennessee, 38138

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49546

  • California Cancer Care, Inc.

    Greenbrae, California, 94904-2007

  • Delta Oncology

    Greenwood, Mississippi, 38930

  • Heartland Hematology Oncology Associates

    Kansas City, Missouri, 64118

  • Regional Hematology Oncology Assoc

    Langhorne, Pennsylvania, 19047

  • Pacific Shores Medical Center

    Long Beach, California, 90813

  • Kenmar Research Institute

    Los Angeles, California, 90057

  • Suniti Medical Corporation

    Merrillville, Indiana, 46410

  • Oncology Hematology Group of South Florida

    Miami, Florida, 33176

  • Pasco Hernando Oncology Associates

    New Port Richey, Florida, 34652

  • Mid-Florida Hematology & Oncology Centers, PA

    Orange City, Florida, 32763

  • Raleigh Hematology Oncology Associates, Wake Practice

    Raleigh, North Carolina, 27609

  • Oncology & Hematology Associates of SW VA

    Roanoke, Virginia, 24014

  • North Coast Cancer Care, Inc.

    Sandusky, Ohio, 44870

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Arch Medical Services/The Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Oncology & Hematology Associates of West Broward

    Tamarac, Florida, 33321

  • Scott & White Hospital/CCPC

    Waco, Texas, 76702

  • Lawrence M. Stallings, MD

    Wooster, Ohio, 44691

Other trials in United States

About this study

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

Conditions
Neoplasms, Diarrhea
Being tested
Sandostatin LAR Depot
Keywords
chemotherapy induced diarrhea, diarrhea, CTID, colorectal cancer, Sandostatin LAR Depot, Sandostatin, adverse events, side effects
Medical subject headings
Neoplasms, Diarrhea, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sandostatin LAR DepotDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2002 (estimated)
  2. Study startDec 2002
  3. Study completionJul 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00050635
Sponsor's protocol ID
CSMS995AUS38
Other IDs
STOP Trial
Status last verified
Nov 2009
First submitted
17 Dec 2002
Last updated
19 Nov 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sandostatin LAR Depot in people with Neoplasms and Diarrhea, run by Novartis Pharmaceuticals at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00050635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2009.

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