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

Information source: University of Turin, Italy
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroendocrine Tumors

Intervention: continuous 5 fluouracil infusion plus long-acting octreotide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Turin, Italy

Official(s) and/or principal investigator(s):
Alfredo Berruti, PHD, Study Chair, Affiliation: Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Luigi Dogliotti, PHD, Study Director, Affiliation: Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Libero Ciuffreda, MD, Principal Investigator, Affiliation: Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino

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.

Clinical Details

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 design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: disease free survival

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Oscar Alabiso, Novara 28100, Italy

Enrica Milanesi, Torino 10126, Italy

Federico Castiglione, Alba, Cuneo 12051, Italy

Davide Perroni, Saluzzo, Cuneo 12037, Italy

Benedetta Ferretti, San Severino Marche, Macerata 62027, Italy

Sebastiano Bombaci, Ivrea, Torino 10015, Italy

Anna Ferrero, Orbassano, Torino 10043, Italy

Additional Information

Starting date: February 2002
Last updated: August 5, 2009

Page last updated: August 23, 2015

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