5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors
This study has been completed.
Sponsor:
University of Turin, Italy
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00953394
First received: August 5, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroendocrine Tumors |
Drug: continuous 5 fluouracil infusion plus long-acting octreotide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by University of Turin, Italy:
Primary Outcome Measures:
- disease free survival [ Time Frame: 50 months ] [ Designated as safety issue: No ]
| Enrollment: | 29 |
| Study Start Date: | February 2002 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: treatment arm
continuous 5 fluouracil infusion plus long-acting octreotide
|
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.
Other Name: metronomic 5 fluouracil infusion plus long-acting octreotide
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953394
Locations
| Italy | |
| Federico Castiglione | |
| Alba, Cuneo, Italy, 12051 | |
| Davide Perroni | |
| Saluzzo, Cuneo, Italy, 12037 | |
| Benedetta Ferretti | |
| San Severino Marche, Macerata, Italy, 62027 | |
| Sebastiano Bombaci | |
| Ivrea, Torino, Italy, 10015 | |
| Anna Ferrero | |
| Orbassano, Torino, Italy, 10043 | |
| Oscar Alabiso | |
| Novara, Italy, 28100 | |
| Enrica Milanesi | |
| Torino, Italy, 10126 | |
Sponsors and Collaborators
University of Turin, Italy
Investigators
| Study Chair: | Alfredo Berruti, PHD | Medical oncology, Department of Clinical and Biological Sciences, University of Turin |
| Study Director: | Luigi Dogliotti, PHD | Medical oncology, Department of Clinical and Biological Sciences, University of Turin |
| Principal Investigator: | Libero Ciuffreda, MD | Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino |
More Information
No publications provided by University of Turin, Italy
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alfredo Berruti, Dipartimento di Scienze Cliniche e Biologiche |
| ClinicalTrials.gov Identifier: | NCT00953394 History of Changes |
| Other Study ID Numbers: | EudraCT 2004-003963-58 |
| Study First Received: | August 5, 2009 |
| Last Updated: | August 5, 2009 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by University of Turin, Italy:
|
octreotide LAR neuroendocrine carcinoma metronomic 5fluorouracil |
Additional relevant MeSH terms:
|
Carcinoma, Neuroendocrine Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Fluorouracil Octreotide |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Hormonal Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 22, 2013