Neuroendocrine TumorsPhase 2NCT00953394
5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors
A Phase 2 study testing continuous 5 fluouracil infusion plus long-acting octreotide in people with Neuroendocrine Tumors, run by University of Turin, Italy at 7 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- continuous 5 fluouracil infusion plus long-acting octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 7 sitesItaly
- Study dates
- Feb 2002to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- adequate bone marrow reserve;
- adequate hepatic and renal function;
- ability to comply with the protocol procedures (including geographic accessibility);
- written informed consent.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Federico Castiglione
Alba, Cuneo, 12051
Sebastiano Bombaci
Ivrea, Torino, 10015
Oscar Alabiso
Novara, 28100
Anna Ferrero
Orbassano, Torino, 10043
Davide Perroni
Saluzzo, Cuneo, 12037
Benedetta Ferretti
San Severino Marche, Macerata, 62027
Enrica Milanesi
Torino, 10126
About this study
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.
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.
Read the 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
- Being tested
- continuous 5 fluouracil infusion plus long-acting octreotide
- Keywords
- octreotide LAR, neuroendocrine carcinoma, metronomic 5fluorouracil
- Medical subject headings
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous 5 fluouracil infusion plus long-acting octreotideDrug
Also called metronomic 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.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | continuous 5 fluouracil infusion plus long-acting octreotide Receives: Drug: continuous 5 fluouracil infusion plus long-acting octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startFeb 2002
- Primary completionFeb 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Alfredo Berruti, PHD, Study chair, Medical oncology, Department of Clinical and Biological Sciences, University of TurinLuigi Dogliotti, PHD, Study director, Medical oncology, Department of Clinical and Biological Sciences, University of TurinLibero Ciuffreda, MD, Principal investigator, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953394
- Sponsor's protocol ID
- EudraCT 2004-003963-58
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19886987
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00953394
- Acronym / sponsor ID
- EudraCT 2004-003963-58
- Conditions
- Neuroendocrine Tumors
- Keywords
- octreotide LAR, neuroendocrine carcinoma, metronomic 5fluorouracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Feb 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: continuous 5 fluouracil infusion plus long-acting octreotidecontinuous 5 fluouracil infusion plus long-acting octreotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous 5 fluouracil infusion plus long-acting octreotideAlso: metronomic 5 fluouracil infusion plus long-acting octreotidelong-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. | Drug | treatment arm |
Primary outcome
disease free survival
Time frame: 50 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
- Derived from this study: PubMed 19886987Brizzi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Berruti, PHD study chair
Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Luigi Dogliotti, PHD study director
Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Libero Ciuffreda, MD principal investigator
Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing continuous 5 fluouracil infusion plus long-acting octreotide in people with Neuroendocrine Tumors, run by University of Turin, Italy at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (time frame: 50 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.