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Colorectal Cancer Stage IIPhase 2CENTRALNCT01853813

First-line Irinotecan, Lederfolin and 5FU (FOLFIRI) and Bevacizumab in Patients With Advanced Colorectal Cancer

A Phase 2 study testing Bevacizumab and FOLFIRI in people with Colorectal Cancer Stage II, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 13 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bevacizumab in combination with chemotherapy represents a standard of care for first-line treatment in patients with advanced colorectal cancer. Molecular predictive factors for bevacizumab efficacy have not yet been identified therefore selection of patients more likely to benefit from such a treatment approach is… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer Stage II
What is being tested?
Bevacizumab and FOLFIRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
13 sitesItaly
Study dates
May 2013to Jul 2015
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • No prior treatment for advanced disease (adjuvant therapy allowed)
  • age < 75 years < 18 years
  • Histologically/cytologically confirmed advanced, colorectal cancer
  • At least one lesion measurable with CT or MRI scan
  • Performance Status (ECOG) 0-1 at study entry)
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  • Life expectancy of at least 6 months
  • Neutrophils count =/> 1.5 x 109/L, platelets count =/> 100 x 109/L, HGB =/> 10 g/dL
  • total bilirubin < 1.5 x UNL • SGOT and SGPT =/< 2.5 x UNL (=/< 5 x UNL in patients with liver metastases)
  • Creatinine < 1.5 x UNL

Who cannot join

  • CNS metastases
  • Severe cardiovascular disease
  • Uncontrolled infections
  • Radiotherapy within 4 weeks of study entry
  • Any experimental drug administered within 4 weeks of study entry
  • Known hypersensitivity to study drug
Show all 10Show fewer
  • Known drugs or alcohol abuse
  • Pregnant or lactating women (serum Betahcg test)
  • Other tumours, except in situ melanoma or cervix cancer if radically removed
  • Incapability to sign informed consent

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Italy13 sites

  • A.O. Universitaria - Ospedali Riuniti

    Ancona, Ancona, 60100

  • A.O. Ospedale G.Rummo

    Benevento, Benevento, 82100

  • Istituto Ospedaliero Fondazione Poliambulanza

    Brescia, Brescia, 25124

  • Ospedale Civile

    Carrara, Massa Carrara, 54033

  • Ospedale Santa Croce

    Fano, PS, 61032

  • Ospedale Maggiore Policlinico

    Milan, Milano, 20122

  • IRCCS Istituto Europeo di Oncologia

    Milan, Milano, 20141

  • A.O. Ospedale S.Paolo

    Milan, MI, 20100

  • Istituto Oncologico Veneto

    Padova, PD, 35124

  • Azienda Ospedaliera San Carlo

    Potenza, PZ, 85100

  • Università Policlinico Umberto I

    Roma, RM, 00186

  • A.O. S.Giovanni Calabita Fatebenefratelli

    Roma, Roma, 00186

  • A.O. Treviglio-Caravaggio, P.le Ospedale n1

    Treviglio, Bergamo, 24047

Other trials in Italy

About this study

Official title: First-line FOLFIRI and Bevacizumab in Patients With Advanced Colorectal Cancer Prospectively Stratified According to Serum LDH

Bevacizumab in combination with chemotherapy represents a standard of care for first-line treatment in patients with advanced colorectal cancer. Molecular predictive factors for bevacizumab efficacy have not yet been identified therefore selection of patients more likely to benefit from such a treatment approach is not possible. Retrospective analyses suggested that LDH serum levels may influence the clinical activity of anti-angiogenetic drugs. Primary aim of our clinical trial will be to prospectively ascertain whether bevacizumab in combination with chemotherapy has an improved clinical activity in patients with high LDH serum levels compared to patients with normal LDH serum levels

Read the detailed description

The VEGF-driven tumour pathway has been demonstrated to represent a novel therapeutic target for an innovative class of antineoplastic agents. Among these antiangiogenetic-targeted treatment modalities the anti-VEGF monoclonal antibody bevacizumab has become a new standard of care for first-line treatment of metastatic colorectal cancer. The biological link between hypoxia, LDH levels and the tumour-driven angiogenesis pathway through the abnormal activation of the hypoxia Inducible factor 1 α (HIF1-α) is well established. HIF1-α is a key transcription factor that up-regulates a series of genes involved in glycolytic metabolism, angiogenesis, cell survival and erythropoiesis Accordingly to this biological assumption Azuma et al (Azuma et al 2007) demonstrated that high LDH serum levels were associated with tumour over-expression of VEGFA and VEGFR-1. As a clinical consequence it has been speculated that LDH levels may represent an indirect indicator of activated tumour angiogenesis and ultimately of worse prognosis We previously analysed the role of LDH pre-treatment serum levels in colorectal cancer patients receiving first-line bevacizumab in metastatic colorectal cancer treated with first-line bevacizumab were eligible. A control group including all consecutive patients treated with chemotherapy alone was also considered. Pre-treatment LDH serum levels were collected for all cases

Being tested
Bevacizumab and FOLFIRI
Keywords
colorectal cancer, advanced disease, LDH
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab and FOLFIRIDrug

    Also called CPT11, Folinic acid, 5FU

    The CENTRAL trial is a biologically enriched prospective phase II clinical trial in which patients treated with first-line modified FOLFIRI and bevacizumab will be prospectively stratified according to LDH serum levels.

    After written informed consent patients will be enrolled. Patients will be considered evaluable for study aim if response rate was radiologically evaluated at least once during treatment course.

    Treatment will be administered until progression, patients' withdrawal of consent, unacceptable toxicity

Study groups in NCT01853813
Study groupRoleWhat they receive
Bevacizumab and FOLFIRIOtherBevacizumab 5 mg/kg d1 q14 in combination with FOLFIRI (Irinotecan, leucovorin, 5FU I.V.bolus and 5FU I.V. c.i.)
Receives: Drug: Bevacizumab and FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    Response rate to ascertain whether bevacizumab in combination with chemotherapy could determine an improved response rate in patients with high LDH serum levels compared to patients with normal LDH serum levels

    Measured: RR will be evaluated every 12 weeks for 24 months

Secondary outcomes (2)

  1. Progression free survival

    Progression free survival to ascertain whether bevacizumab in combination with chemotherapy could determine an improved progression survival in patients with high serum LDH levels compared to patients with normal LDH serum levels

    Measured: 18 months: time from the start of the treatment until PD or death

  2. evaluation of serum IL-8, bFGF, HGF, PlGF, SDF-1, MCP-3

    Methods described by Kopetz et al (Kopetz, JCO 2010)

    Measured: every 12 weeks for 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionMay 2015
  4. Study completionJul 2015

Resources

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
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01853813
Sponsor's protocol ID
2012-005048-46
Acronym
CENTRAL
Status last verified
Jul 2015
First submitted
21 Mar 2013
Last updated
15 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and FOLFIRI in people with Colorectal Cancer Stage II, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 13 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 10 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 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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?

Response Rate (time frame: RR will be evaluated every 12 weeks for 24 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 NCT01853813.

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 15 Jul 2015.

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