Expired Study
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Tampa, Florida 33612


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00092287


Primary Contact:

Study Director
France Catus, MD
Ipsen


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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