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

NCT ID: NCT00953394

Last Updated: 2009-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2006-12-31

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 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.

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).

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.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

continuous 5 fluouracil infusion plus long-acting octreotide

Group Type: EXPERIMENTAL

continuous 5 fluouracil infusion plus long-acting octreotide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

metronomic 5 fluouracil infusion plus long-acting octreotide

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Dipartimento di Scienze Cliniche e Biologiche

Principal Investigators

Alfredo Berruti, PHD

Role: STUDY_CHAIR

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

Luigi Dogliotti, PHD

Role: STUDY_DIRECTOR

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

Libero Ciuffreda, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino

Locations

Federico Castiglione

Alba, Cuneo, Italy

Davide Perroni

Saluzzo, Cuneo, Italy

Benedetta Ferretti

San Severino Marche, Macerata, Italy

Sebastiano Bombaci

Ivrea, Torino, Italy

Anna Ferrero

Orbassano, Torino, Italy

Oscar Alabiso

Novara, , Italy

Enrica Milanesi

Torino, , Italy

Countries

Italy

References

Brizzi MP, Berruti A, Ferrero A, Milanesi E, Volante M, Castiglione F, Birocco N, Bombaci S, Perroni D, Ferretti B, Alabiso O, Ciuffreda L, Bertetto O, Papotti M, Dogliotti L. Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte oncology network. BMC Cancer. 2009 Nov 3;9:388. doi: 10.1186/1471-2407-9-388.

Reference Type: DERIVED

PMID: 19886987 (View on PubMed)

Other Identifiers

EudraCT 2004-003963-58

Identifier Type: -

Identifier Source: org_study_id