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

Neuroendocrine Tumors Clinical Trial

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.

Clinical Trial 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 Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00953394
Study type Interventional
Source University of Turin, Italy
Contact
Status Completed
Phase Phase 2
Start date February 2002
Completion date December 2006
View Details
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