drugset / Trial / NCT00953394

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

NCT00953394

Phase 2 Completed 29 enrolled University of Turin, Italy
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2002-02
Primary completion
2006-02
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Octreotide Peptide 20 mg Intramuscular
Subject fluorouracil Small molecule 200 mg/m2 Intravenous