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.
Verified date | August 2009 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: The Italian Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | December 2006 |
Est. primary completion date | February 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Federico Castiglione | Alba | Cuneo |
Italy | Sebastiano Bombaci | Ivrea | Torino |
Italy | Oscar Alabiso | Novara | |
Italy | Anna Ferrero | Orbassano | Torino |
Italy | Davide Perroni | Saluzzo | Cuneo |
Italy | Benedetta Ferretti | San Severino Marche | Macerata |
Italy | Enrica Milanesi | Torino |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease free survival | 50 months | No |
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