Clinical trial NCT00171873: Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Official title: Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuroendocrine Tumors
Keywords: Double blind
Phase III
Disease
Clinical trial
Octreotide
Neuroendocrine tumor
Cancer
Tumor
Midgut
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
timeFrame: Up to 7 years
Secondary outcomes:
measure: Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
timeFrame: at 3 month intervals
measure: Biochemical Response at 3 Month Intervals
timeFrame: at 3 month intervals up to 18 moths
measure: Symptom Control at 3 Month Intervals
timeFrame: at 3 month intervals up to 18 moths
measure: Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study
timeFrame: at three-month intervals
measure: Survival
timeFrame: at least on a monthly basis
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Philipps University Marburg
name: Rudolf Arnold, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24.