George A. Fisher Jr.
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingIntervention(s):
- Drug: lanreotide
- Drug: placebo
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to 75 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- histopathologically confirmed diagnosis of carcinoid tumor
- history of carcinoid syndrome (flushing and/or diarrhea)
- either naive to treatment with a Somatostatin analog or responsive to conventional doses of LAR or subcutaneous octreotide
- confirmation of positive somatostatin receptor status by somatostatin receptor scintigraphy
- absence of tumor progression
Key Exclusion Criteria:
- history of carcinoid syndrome refractory to treatment with conventional doses of Somatostatin analogs
- treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled Somatostatin analog and/or tumor debulking < 3 months prior to study entry
- history of hepatic arterial embolization
- short bowel syndrome
- uncontrolled diabetes and/or hypertension
- severe renal impairment and/or liver impairment
- diagnosis of cardiac disease
Additional Study Details
Official Title:
A Double-Blind, Randomized Placebo-Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid SyndromeAnticipated start date:
3/1/2009Lead Sponsor:
IpsenInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Usage of subcutaneous octreotide required to control symptoms associated with carcinoid syndrome, during the 16-week double-blind phase of the study based on patient IVRS diary records
Total Number to be Enrolled:
100Total Number to be Enrolled at Stanford:
5More Information
Secondary ID(s):
- 2-55-52030-730
- END0007
- NCT00774930
- TR321
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/13/2011PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help