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

August 5, 2009 updated by: University of Turin, Italy

Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Metastatic or locally advanced well differentiated neuroendocrine carcinoma were treated with 5Fluorouracil protracted intravenous infusion (200 mg/m2 daily) plus Octreotide LAR (20 mg monthly).

Primary Endpoint: the response to treatment, evaluated according to the RECIST criteria.

Secondary Endpoints:

  • toxicity, graded according to the NCI-CTG criteria;
  • symptomatic response: evaluated according to the changes in both the frequency and intensity of symptoms;
  • biochemical response: evaluated considering the changes in the tumor marker levels (circulating Chromogranin A);
  • time to progression and survival: were measured from the date of treatment start to the date of progression and the date of last follow-up or death, respectively.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • Oscar Alabiso
      • Torino, Italy, 10126
        • Enrica Milanesi
    • Cuneo
      • Alba, Cuneo, Italy, 12051
        • Federico Castiglione
      • Saluzzo, Cuneo, Italy, 12037
        • Davide Perroni
    • Macerata
      • San Severino Marche, Macerata, Italy, 62027
        • Benedetta Ferretti
    • Torino
      • Ivrea, Torino, Italy, 10015
        • Sebastiano Bombaci
      • Orbassano, Torino, Italy, 10043
        • Anna Ferrero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification;
  • locally advanced or metastatic disease not amenable to surgery with radical intent;
  • at least one measurable target lesion;
  • radiological documentation of progressive disease;
  • ECOG performance status grade <=2;
  • life expectancy >12 weeks;
  • adequate bone marrow reserve;
  • adequate hepatic and renal function;
  • ability to comply with the protocol procedures (including geographic accessibility);
  • written informed consent.

Exclusion Criteria:

  • non-malignant systemic disease or conditions that precluded patients from receiving the study therapy;
  • second primary malignancies and previous systemic antineoplastic treatment including somatostatin analogues;
  • history of prior malignancy, excepted for cured non-melanoma skin cancer, and cured in situ cervical carcinoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment arm
continuous 5 fluouracil infusion plus long-acting octreotide
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.
Other Names:
  • metronomic 5 fluouracil infusion plus long-acting octreotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease free survival
Time Frame: 50 months
50 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Study Chair: Alfredo Berruti, PHD, Medical oncology, Department of Clinical and Biological Sciences, University of Turin
  • Study Director: Luigi Dogliotti, PHD, Medical oncology, Department of Clinical and Biological Sciences, University of Turin
  • Principal Investigator: Libero Ciuffreda, MD, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 5, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2004-003963-58

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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