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

Carmen Schade-Brittinger

Status and phase: Completed; Phase 3

Conditions: Neuroendocrine Tumors

Treatments: Drug: Placebo; Drug: Octreotide LAR (Long-acting release)

Study type: Interventional

Funder types: Other

Identifiers

NCT00171873

CSMS995ADE05

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 2 patient groups, including a placebo group

Octreotide LAR (Long Acting Release)

Experimental group

Description:

Octreotide LAR 30 mg intramuscularly every 28 days

Treatment:

Drug: Octreotide LAR (Long-acting release)

Placebo

Placebo Comparator group

Description:

Placebo - Sodium chloride intramuscularly every 28 days

Treatment:

Drug: Placebo