Status:
COMPLETED
5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors
Lead Sponsor:
University of Turin, Italy
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Well differentiated neuroendocrine carcinomas have low proliferative activity and conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent administration of cytotoxic d...
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). Prim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00953394
Start Date
February 1 2002
End Date
December 1 2006
Last Update
August 6 2009
Active Locations (7)
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1
Federico Castiglione
Alba, Cuneo, Italy, 12051
2
Davide Perroni
Saluzzo, Cuneo, Italy, 12037
3
Benedetta Ferretti
San Severino Marche, Macerata, Italy, 62027
4
Sebastiano Bombaci
Ivrea, Torino, Italy, 10015