An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome (ELECT)

• Frequency of diarrhea events (per day) based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
• Frequency of flushing events (per day) based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
• Usage of other rescue medications for diarrhea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
• Proportion of patients who roll over into the open-label phase before completing the double-blind phase of the study. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
• Changes from baseline in Quality of Life (QoL); assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30-Carcinoid/NETs module: EORTC QLQ-G.I. NET 21 [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
• Absolute changes from baseline in biochemical marker - plasma Chromogranin A (CgA). [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
• Absolute changes from baseline in biochemical marker - urinary 5-hydroxyindoleacetic acid (5-HIAA). [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]

The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome. In countries where Somatuline Depot is not approved, patients well controlled at the end of the open-label phase will be able to participate in a long-term open-label extension phase.

• Drug: Somatuline Depot (lanreotide)
  subcutaneous injection, 120 mg, q28d
  Other Name: Somatuline Autogel
• Drug: placebo
  inactive substance

• Experimental: Somatuline Depot 120 mg
  Intervention: Drug: Somatuline Depot (lanreotide)
• Placebo Comparator: Placebo
  Intervention: Drug: placebo

Inclusion Criteria:

• histopathologically confirmed diagnosis of carcinoid tumor or a carcinoid tumor of unknown location with liver metastases
• history of carcinoid syndrome (flushing and/or diarrhea)
• either naive to treatment with a Somatostatin analog or responsive to conventional doses of LAR or subcutaneous octreotide
• confirmation of positive somatostatin receptor status by somatostatin receptor scintigraphy
• absence of tumor progression

Exclusion Criteria:

• history of carcinoid syndrome refractory to treatment with conventional doses of Somatostatin analogs
• treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled Somatostatin analog and/or tumor debulking < 3 months prior to study entry
• history of hepatic arterial embolization
• short bowel syndrome
• uncontrolled diabetes and/or hypertension
• severe renal impairment and/or liver impairment
• diagnosis of cardiac disease