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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: continuous 5 fluouracil infusion plus long-acting octreotide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>continuous 5 fluouracil infusion plus long-acting octreotide | Drug: continuous 5 fluouracil infusion plus long-acting octreotide<br>* 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.<br>* Other names: metronomic 5 fluouracil infusion plus long-acting octreotide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | 50 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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octreotide LAR, neuroendocrine carcinoma, metronomic 5fluorouracil