5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors
|ClinicalTrials.gov Identifier: NCT00953394|
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 6, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: continuous 5 fluouracil infusion plus long-acting octreotide||Phase 2|
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.
- 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 (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||February 2002|
|Primary Completion Date :||February 2006|
|Study Completion Date :||December 2006|
Experimental: treatment arm
continuous 5 fluouracil infusion plus long-acting octreotide
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.
Other Name: metronomic 5 fluouracil infusion plus long-acting octreotide
- disease free survival [ Time Frame: 50 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953394
|Alba, Cuneo, Italy, 12051|
|Saluzzo, Cuneo, Italy, 12037|
|San Severino Marche, Macerata, Italy, 62027|
|Ivrea, Torino, Italy, 10015|
|Orbassano, Torino, Italy, 10043|
|Novara, Italy, 28100|
|Torino, Italy, 10126|
|Study Chair:||Alfredo Berruti, PHD||Medical oncology, Department of Clinical and Biological Sciences, University of Turin|
|Study Director:||Luigi Dogliotti, PHD||Medical oncology, Department of Clinical and Biological Sciences, University of Turin|
|Principal Investigator:||Libero Ciuffreda, MD||Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino|