Overview

This trial is active, not recruiting.

Condition neuroendocrine tumors
Treatments octreotide lar (long-acting release), placebo
Phase phase 3
Sponsor Carmen Schade-Brittinger
Start date September 2001
End date June 2008
Trial size 85 participants
Trial identifier NCT00171873, CSMS995ADE05, NCT00202085

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Octreotide LAR 30 mg intramuscularly every 28 days
octreotide lar (long-acting release) SMS995
30 mg intramuscularly every 28 days
(Placebo Comparator)
Placebo - Sodium chloride intramuscularly every 28 days
placebo
Sodium chloride intramuscularly every 28 days

Primary Outcomes

Measure
Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
time frame: Up to 7 years

Secondary Outcomes

Measure
Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
time frame: at 3 month intervals
Biochemical Response at 3 Month Intervals
time frame: at 3 month intervals up to 18 moths
Symptom Control at 3 Month Intervals
time frame: 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
time frame: at three-month intervals
Survival
time frame: at least on a monthly basis

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Principal investigator Rudolf Arnold, MD, Prof
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Philipps University Marburg Medical Center.