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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00953394
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 6, 2009
Information provided by:
University of Turin, Italy

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : February 2002
Actual Primary Completion Date : February 2006
Actual Study Completion Date : December 2006

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 Name: metronomic 5 fluouracil infusion plus long-acting octreotide

Primary Outcome Measures :
  1. disease free survival [ Time Frame: 50 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00953394

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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
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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 automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alfredo Berruti, Dipartimento di Scienze Cliniche e Biologiche Identifier: NCT00953394    
Other Study ID Numbers: EudraCT 2004-003963-58
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009
Keywords provided by University of Turin, Italy:
octreotide LAR
neuroendocrine carcinoma
metronomic 5fluorouracil
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Hormonal