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

University of Turin

Status and phase

Completed

Phase 2

Conditions

Neuroendocrine Tumors

Treatments

Drug: continuous 5 fluouracil infusion plus long-acting octreotide

Study type

Interventional

Funder types

Other

Identifiers

NCT00953394

EudraCT 2004-003963-58

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.