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

This study has been completed.
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00953394
First received: August 5, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Neuroendocrine Tumors
Drug: continuous 5 fluouracil infusion plus long-acting octreotide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 50 months ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: February 2002
Study Completion Date: December 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: metronomic 5 fluouracil infusion plus long-acting octreotide

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953394

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

No publications provided by University of Turin, Italy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alfredo Berruti, Dipartimento di Scienze Cliniche e Biologiche
ClinicalTrials.gov Identifier: NCT00953394     History of Changes
Other Study ID Numbers: EudraCT 2004-003963-58
Study First Received: August 5, 2009
Last Updated: August 5, 2009
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Turin, Italy:
octreotide LAR
neuroendocrine carcinoma
metronomic 5fluorouracil

Additional relevant MeSH terms:
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Fluorouracil
Octreotide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 22, 2014