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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171873
• Other study ID #: CSMS995ADE05
• Status: Completed
• Phase: Phase 3
• Start date: September 2001
• Est. completion date: December 2013

Study information

• Verified date: March 2020
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00202085

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2013
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neuroendocrine Tumors

Intervention

Drug:
• Octreotide LAR (Long-acting release)
30 mg intramuscularly every 28 days
• Placebo
Sodium chloride intramuscularly every 28 days

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Munchen

Sponsors (1)

Lead Sponsor	Collaborator
Carmen Schade-Brittinger

Country where clinical trial is conducted

Germany, 

Outcome

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