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.
- 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.
- 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
- 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.