NCT00953394

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-02-01
• Primary completion: 2006-02-01
• Completion: 2006-12-01
• First posted: 2009-08-06
• Last updated: 2009-08-06

Locations

7 sites across 1 country: Italy