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5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors

NCT00953394 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2009-08-06

No results posted yet for this study

Summary

Well differentiated neuroendocrine carcinomas have low proliferative activity and conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties. Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing metronomic chemotherapy in this clinical setting.

A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU) infusion plus long-acting release (LAR) octreotide for patients with neuroendocrine carcinoma.

Conditions

Interventions

DRUG

continuous 5 fluouracil infusion plus long-acting octreotide

long-acting octreotide acetate at a dose of 20 mg was administered intramuscularly every 4 weeks. 5fluorouracil was given as a protracted continuous infusion without interruption at a daily dose of 200 mg/m2 of body-surface area through an elastomeric pump connected to a central venous access.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Alfredo Berruti, PHD · Medical oncology, Department of Clinical and Biological Sciences, University of Turin

  • Luigi Dogliotti, PHD · Medical oncology, Department of Clinical and Biological Sciences, University of Turin

  • Libero Ciuffreda, MD · Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2006-02-28
Completion
2006-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953394 on ClinicalTrials.gov