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

University of Turin, Italy29 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroendocrine Tumors

Interventions

continuous 5 fluouracil infusion plus long-acting octreotideDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (7)

Federico Castiglione

Alba, Cuneo, Italy

Davide Perroni

Saluzzo, Cuneo, Italy

Benedetta Ferretti

San Severino Marche, Macerata, Italy

Sebastiano Bombaci

Ivrea, Torino, Italy

Outcomes

Primary Outcomes

disease free survival

Time frame: 50 months

Data from ClinicalTrials.gov

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