Clinical trial NCT00050635: STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasms
Diarrhea
Keywords: chemotherapy induced diarrhea
diarrhea
CTID
colorectal cancer
Sandostatin LAR Depot
Sandostatin
adverse events
side effects
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2002-12-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Kenmar Research Institute
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care medical Group, Inc.
state: California
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Center
state: California
city: Los Angeles
country: United States
facility: Kenmar Research Institute
state: California
city: Miami
country: United States
facility: Oncology Hematology Group of South Florida
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology Associates
state: Florida
city: Orange City
country: United States
facility: Mid-Florida Hematology & Oncology Centers, PA
state: Florida
city: Tamarac
country: United States
facility: Oncology & Hematology Associates of West Broward
state: Florida
city: Chicago
country: United States
facility: Creticos Cancer Center
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Bloomington
country: United States
facility: Cancer Care Center
state: Indiana
city: Merrillville
country: United States
facility: Suniti Medical Corporation
state: Indiana
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan
state: Michigan
city: Greenwood
country: United States
facility: Delta Oncology
state: Mississippi
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Kansas City
country: United States
facility: Heartland Hematology Oncology Associates
state: Missouri
city: St. Louis
country: United States
facility: Arch Medical Services/The Center for Cancer Care and Research
state: Missouri
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: E. Setauket
country: United States
facility: North Shore Hematology Oncology
state: New York
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates, Wake Practice
state: North Carolina
city: Fargo
country: United States
facility: Dakota Clinic/Odyssey Research Services
state: North Dakota
city: Canton
country: United States
facility: Nashat Y. Gabrail, MD
state: Ohio
city: Sandusky
country: United States
facility: North Coast Cancer Care, Inc.
state: Ohio
city: Wooster
country: United States
facility: Lawrence M. Stallings, MD
state: Ohio
city: Drexel Hill
country: United States
facility: Consultants in Medical Oncology-Hematology
state: Pennsylvania
city: Langhorne
country: United States
facility: Regional Hematology Oncology Assoc
state: Pennsylvania
city: Borden
country: United States
facility: Oncology Services of Aberdeen
state: South Dakota
city: Germantown
country: United States
facility: Jones Oncolgy/Hematology Clinic
state: Tennessee
city: Beaumont
country: United States
facility: McFaddin Ward Cancer - TOPA
state: Texas
city: Waco
country: United States
facility: Scott & White Hospital/CCPC
state: Texas
city: Roanoke
country: United States
facility: Oncology & Hematology Associates of SW VA
state: Virginia
Study officials:
References: