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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953394
• Other study ID #: EudraCT 2004-003963-58
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2009
• Last updated: August 5, 2009
• Start date: February 2002
• Est. completion date: December 2006

Study information

• 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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma, Neuroendocrine
• Neuroendocrine Tumors

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival		50 months	No