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

This study has been completed.

First Received on December 17, 2002. Last Updated on November 18, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Collaborator:	Quintiles
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00050635

Purpose

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	Intervention	Phase
Neoplasms Diarrhea	Drug: Sandostatin LAR Depot	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diarrhea

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment:	150
Study Start Date:	December 2002
Estimated Study Completion Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050635

Show 34 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Quintiles

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00050635 History of Changes
Other Study ID Numbers:	CSMS995AUS38, STOP Trial
Study First Received:	December 17, 2002
Last Updated:	November 18, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

chemotherapy induced diarrhea
diarrhea
CTID
colorectal cancer

Sandostatin LAR Depot
Sandostatin
adverse events
side effects

Additional relevant MeSH terms:

Neoplasms
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Octreotide

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 12, 2012