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

Primary Purpose

Neuroendocrine Tumors

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
continuous 5 fluouracil infusion plus long-acting octreotide
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring octreotide LAR, neuroendocrine carcinoma, metronomic 5fluorouracil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Federico Castiglione
  • Davide Perroni
  • Benedetta Ferretti
  • Sebastiano Bombaci
  • Anna Ferrero
  • Oscar Alabiso
  • Enrica Milanesi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

continuous 5 fluouracil infusion plus long-acting octreotide

Outcomes

Primary Outcome Measures

disease free survival

Secondary Outcome Measures

Full Information

First Posted
August 5, 2009
Last Updated
August 5, 2009
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00953394
Brief Title
5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Turin, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
octreotide LAR, neuroendocrine carcinoma, metronomic 5fluorouracil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
continuous 5 fluouracil infusion plus long-acting octreotide
Intervention Type
Drug
Intervention Name(s)
continuous 5 fluouracil infusion plus long-acting octreotide
Other Intervention Name(s)
metronomic 5 fluouracil infusion plus long-acting octreotide
Intervention Description
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.
Primary Outcome Measure Information:
Title
disease free survival
Time Frame
50 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo Berruti, PHD
Organizational Affiliation
Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luigi Dogliotti, PHD
Organizational Affiliation
Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Libero Ciuffreda, MD
Organizational Affiliation
Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federico Castiglione
City
Alba
State/Province
Cuneo
ZIP/Postal Code
12051
Country
Italy
Facility Name
Davide Perroni
City
Saluzzo
State/Province
Cuneo
ZIP/Postal Code
12037
Country
Italy
Facility Name
Benedetta Ferretti
City
San Severino Marche
State/Province
Macerata
ZIP/Postal Code
62027
Country
Italy
Facility Name
Sebastiano Bombaci
City
Ivrea
State/Province
Torino
ZIP/Postal Code
10015
Country
Italy
Facility Name
Anna Ferrero
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Oscar Alabiso
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Enrica Milanesi
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19886987
Citation
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.
Results Reference
derived

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

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