STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
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ClinicalTrials.gov Identifier: NCT00050635 |
Recruitment Status :
Completed
First Posted : December 18, 2002
Last Update Posted : November 19, 2009
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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 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 |
- Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

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 |
chemotherapy induced diarrhea diarrhea CTID colorectal cancer |
Sandostatin LAR Depot Sandostatin adverse events side effects |
Diarrhea Signs and Symptoms, Digestive Octreotide |
Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |