Phase 3 N=85 Randomized Quadruple-blind Treatment

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

Neuroendocrine Tumors

Bottom Line

View on ClinicalTrials.gov: NCT00171873 ↗

Enrolled (actual)

Serious AEs

24.7%

Results posted

Mar 2011

Primary outcome: Primary: Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) — 14.3; 6.0 Months

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Octreotide LAR (Long-acting release) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Carmen Schade-Brittinger
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)	14.3; 6.0	—
SECONDARY Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals	—	—
SECONDARY Biochemical Response at 3 Month Intervals	—	—
SECONDARY Symptom Control at 3 Month Intervals	—	—
SECONDARY Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study	—	—
SECONDARY Survival	—	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00171873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.