Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut

Inclusion Criteria:

• Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut
• curative surgery impossible
• two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
• Age ≥ 18
• Karnofsky-index > 60
• written informed consent
• proliferation index for Ki67

Exclusion Criteria:

• hypersensitivity to octreotide
• poorly differentiated or small cell neuroendocrine tumors
• primary tumor outside of the midgut
• prior treatment with somatostatin-analogue > 4 weeks
• prior treatment with alpha-interferon, chemotherapy, or chemoembolisation
• participation in any other clinical trial
• pregnancy or lactation
• no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years
• severe decompensated organ malfunction (heart-, liver- insufficiency)

Other protocol-defined exclusion criteria may apply.