Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome

• Status: Terminated
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Angiopeptin; Lanreotide; Octreotide; Somatostatin

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.