Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuroendocrine Tumors
Intervention: Octreotide (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis
Summary
Placebo-controlled prospective randomized phase III study to investigate the
antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of
the midgut
Clinical Details
Official title: Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to tumor progression documented by CT or MRT
Secondary outcome: Objective response rates according to WHO criteria at 3 month intervalsBiochemical response at 3 month intervals Symptom control at 3 month intervals
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 CT or 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.
Locations and Contacts
Marburg 35033, Germany
Additional Information
Starting date: August 2001
Last updated: May 1, 2008
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