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

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

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

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: Octreotide LAR (Long-acting release)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide LAR (Long Acting Release)<br>Octreotide LAR 30 mg intramuscularly every 28 days | Drug: Octreotide LAR (Long-acting release)<br>* 30 mg intramuscularly every 28 days<br>* Other names: SMS995;|
| Placebo Comparator: Placebo<br>Placebo - Sodium chloride intramuscularly every 28 days | Drug: Placebo<br>* Sodium chloride intramuscularly every 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008. | Up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals |  | at 3 month intervals | 
| Biochemical Response at 3 Month Intervals |  | at 3 month intervals up to 18 moths | 
| Symptom Control at 3 Month Intervals |  | at 3 month intervals up to 18 moths | 
| Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study |  | at three-month intervals | 
| Survival |  | at least on a monthly basis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double blind, Phase III, Disease, Clinical trial, Octreotide, Neuroendocrine tumor, Cancer, Tumor, Midgut