DRUG
Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
Status
Terminated
Phase
Phase 3
Enrollment
4
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with carcinoid syndrome.
Interventions
Treatment arms and agents.
DRUG
Sandostatin long acting release (LAR) Depot (somatostatin analogue)
Timeline
From registration to results.
First posted
Sep 27, 2004
Study start
Jul 2004
Primary completion
Not reported
Study completion
Oct 2004
Results posted
Not reported
Registry updated
Apr 30, 2020
Outcomes
What the study measures.
Primary outcomes
Target symptom frequency (flushing or stool frequency).
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type. * Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to a primary tumor of the lung, stomach or mid-gut. * Previous positive Octreoscan. * World Health Organization (WHO) performance score lower than 2. At the baseline visit patients MUST satisfy the following criteria before they are randomized to receive study treatment: * Stool and/or flushing frequency of greater than or equal to 3 episodes/day (average over a minimum five consecutive days). * Patients who have previously been treated with somatostatin analogues must have discontinued treatment for a sufficient period of time (a washout period of at least 7 days for immediate release formulations and up to 2 months for prolonged release formulations is usually required). Compared with their "controlled" state on treatment, these patients must show a clinically significant deterioration (at least two episodes) of either symptom. For example, a patient considered to be controlled on their previous treatment with an estimated stool frequency of two episodes per day, must achieve a stool frequency of at least four episodes per day (average over a minimum five consecutive days). * WHO performance score lower than 2. Exclusion Criteria: * VIPoma or other non-carcinoid tumor. * Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to inclusion, or planned during the study. * Radionuclide treatment within three months prior to inclusion, or planned during the study. * Presence of other active malignant pathology (except basal cellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus). * Surgical procedure or embolization procedure (with or without cytotoxic agents) of the tumor within three months prior to inclusion, or planned during the study. * Life expectancy of less than 6 months. * Any investigational drug given within 30 days prior to inclusion or expected to be given during the study. * No access to a telephone for completion of the daily telephone diary.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Larry Kvols, MD
Tampa, Florida, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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