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

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

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Key information

Conditions

Neoplasms Colonic Diseases Colorectal Neoplasms Diarrhea Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kenmar Research Institute, Burbank, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sandostatin LAR Depot

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

Quintiles, Inc.

Registry information

Important dates

Study start: 2002
Study completion: 2003
First posted: Dec 18, 2002
Registry last updated: Nov 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed