Malignant Carcinoid Syndrome
Conditions
Keywords
Carcinoid Syndrome, Neuroendocrine Tumuors
Brief summary
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
DRUGlanreotide Autogel (somatostatin analogue)
DRUGSandostatin long acting release (LAR) Depot (somatostatin analogue)
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target symptom frequency (flushing or stool frequency). | — |
Countries
United States
Outcome results
None listed