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Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.


Phase 2
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Tumors

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Trial Information

Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival

Outcome Time Frame:

50 months

Safety Issue:

No

Principal Investigator

Alfredo Berruti, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical oncology, Department of Clinical and Biological Sciences, University of Turin

Authority:

Italy: The Italian Medicines Agency

Study ID:

EudraCT 2004-003963-58

NCT ID:

NCT00953394

Start Date:

February 2002

Completion Date:

December 2006

Related Keywords:

  • Neuroendocrine Tumors
  • octreotide LAR
  • neuroendocrine carcinoma
  • metronomic 5fluorouracil
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Tumors

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