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Advanced Colorectal CancerDISTINCTIVENCT04252456

Folfiri/aflIbercept in Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status

A study testing Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan in people with Advanced Colorectal Cancer, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 16 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The study will a be a biologically enriched, prospectively stratified phase II trial in RAS wild type metastatic colorectal cancer patients progressing after first-line treatment with oxaliplatin, fluoropyrimidines and an anti-EGFR monoclonal antibody. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
16 sitesItaly
Study dates
23 Apr 2018to Feb 2021
Phase
Interventional
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 confirmation of colorectal cancer
  • Confirmed RAS wild type patient treated with an oxaliplatin-anti EGFR treatment in 1st line
  • At least one lesion measurable with CT or MRI scan
  • Radiologically documented progression while on or after discontinuation of treatment with FOLFOX in combination with an anti-EGFR monoclonal antibody (either cetuximab or panitumumab)
  • Radiologically documented progressing disease after FOLFOX in combination with an anti-EGFR monoclonal antibody (either cetuximab or panitumumab)
  • Life expectancy plus 3 months
Show all 17Show fewer
  • Netrophils count ³ 1.5 x 109/L
  • Platelets count ³ 100 x 109/L
  • Hemoglobin ³ 9 g/dL
  • Creatinine £ 1.5 mg/dL, Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour.Bilirubin £ 1.5 x ULN
  • AST and ALT £ 2.5 x ULN (< 5 ULN in case of liver metastases)
  • Informed written consent
  • ECOG Performance Status < 2
  • Age plus18 yrs
  • Regular follow-up feasible.
  • For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior of starting study treatment,
  • Female patients must commit to using reliable and appropriate methods of contraception until at least six months after the end of study treatment

Who cannot join

  • • Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
  • Treatment with any other investigational medicinal product within 28 days prior to First Study treatment.
  • Other serious and uncontrolled non-malignant disease,
  • History or evidence upon physical examination of CNS metastasis unless adequately treated
  • Gilbert's syndrome
  • Intolerance to atropine sulfate or loperamide
Show all 17Show fewer
  • Known dihydropyrimidine dehydrogenase deficiency
  • Treatment with CYP3A4 inducers unless discontinued > 7 days prior to First Study treatment.
  • Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis.
  • Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
  • Major surgery or traumatic injury within the last 28 days or until the surgical wound is fully healed whichever came later
  • Pregnant or breastfeeding women,
  • Patients with known allergy to any excipient to study drugs,
  • Bowel obstruction.
  • Uncontrolled infections
  • Known drugs or alcohol abuse
  • History of severe cardiovascular disease within 6 months prior to First Study treatment Uncontrollable hypertension, when treated with three or more drugs.

Trial locations and contacts

16 sites in 1 country.

Silvia Rota, DM contact

+39 02 84968409

centrotrialgiscad@yahoo.it

Eleonora Lai, DM contact

+39 392 2886023

sperimentazioniclinicheunica@gmail.com

16 sites in 1 country

Italy16 sites, 11 recruiting

  • Centro Riferimento

    Aviano, PN, 33081

    Active, not recruiting

  • A.O. Humanitas Gavazzeni

    Bergamo, BG, 24125

    Giordano D Beretta, MD

    Recruiting

  • Ospedale Papa Giovanni XXIII

    Bergamo

    Stefania Mosconi, MD

    Stefania Mosconi, MD

    Recruiting

  • Fondazione Poliambulanza, Via Bissolati 57

    Brescia, 25100

    Alberto Zaniboni, MD

    Recruiting

  • A.O. Polo Oncologico Vito Fazzi

    Lecce, LE, 73100

    Silvana Leo, MD

    Not yet recruiting

  • IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Active, not recruiting

  • IRCCS Istituto Europeo di Oncologia

    Milan, 20141

    Active, not recruiting

  • A.O.U. Policlinico di Modena

    Modena, 41124

    Gabriele Luppi, MD

    Recruiting

  • Policlinico Universitario D.Casula

    Monserrato, Cagliari, 09121

    Mario Scartozzi, PhD

    Mario Scartozzi, PhD

    Recruiting

  • AUSL di Piacenza

    Piacenza, PC, 29100

    Luigi Cavanna, MD, +39 0523 302697, l.cavanna@ausl.pc.it

    Luigi Cavanna, MD

    Recruiting

  • Azienda Ospedaliera San Carlo

    Potenza, PZ, 85100

    Giuseppe Rosati, MD

    Domenico Bilancia, MD

    Recruiting

  • ASST-Rhodense

    Rho, Milano, 20017

    Sara DiBella, MD

    Roberto Bollina, MD

    Recruiting

  • A.O. S.Giovanni Calabita Fatebenefratelli

    Roma, 00186

    Active, not recruiting

  • Istituto Clinico Humanitas

    Rozzano, MI, 20133

    Lorenza Rimassa, MD

    Recruiting

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

    Treviglio, Bergamo, 24047

    Active, not recruiting

  • Ospedale San Bortolo

    Vicenza, 36100

    Giuseppe Aprile, MD

    Recruiting

Other trials in Italy

About this study

Official title: seconD-line Folfiri/aflIbercept in proSpecTIvely Stratified, Anti-EGFR resistaNt, Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status

The study will a be a biologically enriched, prospectively stratified phase II trial in RAS wild type metastatic colorectal cancer patients progressing after first-line treatment with oxaliplatin, fluoropyrimidines and an anti-EGFR monoclonal antibody.

All patients will receive aflibercept in combination with FOLFIRI according to the Italian label.

Read the detailed description

The study will a be a biologically enriched, prospectively stratified phase II trial in RAS wild type metastatic colorectal cancer patients progressing after first-line treatment with oxaliplatin, fluoropyrimidines and an anti-EGFR monoclonal antibody. Eligible patients will be prospectively allocated to either of two groups according to VEGFR2 levels (ELISA-based technique, pg/ml) at study entry.

Others angiogenetic factors levels concentration before and during treatment. VEGF, PlGF, HGF, VEGFR1, IL8, IL1a, T-cad, VEGFR3, SAP, VDBP, neuropilin1, CRP, endoglin plasma concentrations will be evaluated before each cycle according to an ELISA-based technique All patients will undergo a blood test for retrieving circulating tumor DNA (Liquid Biopsy) at selected time-points before and during treatment for determining whether the status of selected tumor biomarkers evolve during tumor progression by comparing different ctDNA samples.

All patients will receive aflibercept in combination with FOLFIRI according to the Italian label.

Being tested
Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan

What participants receive

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

  • Aflibercept, 5fluorouracil, Folinic Acid andIrinotecanProcedure or surgery

    All patients will receive aflibercept in combination with FOLFIRI according to the Italian label

Study groups in NCT04252456
Study groupRoleWhat they receive
standard chemotherapy for advanced colorectal cancerOtherAll patients will receive aflibercept in combination with FOLFIRI according to the Italian label.
Receives: Procedure: Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan

What is being measured

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

  1. Overall survival (OS) according to VEGFR2 levels, evaluating the difference in terms of median OS among patients with high VEGFR2 activity and patients with low VEGFR2 activity

    Overall survival time is defined as the time from inclusion to the date of death. If subject has not died, survival will be censored on the last date the subject was known to be alive (last date of follow-up)

    Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 3 years

Secondary outcomes (4)

  1. Progression free survival (PFS) defined as the interval between the start of Aflibercept-FOLFIRI therapy to tumor progression or death or last follow up visit if not progressed

    PFS time will defined as the time of inclusion until the date of first observed disease progression or death due to any cause, if death occurs before progression is documented

    Measured: time from the start of treatment untill the date of first documented progression or death from any cause, whichever came first, assessed up to 3 years

  2. Response rate (RR) defined according to the Response Evaluation Criteria in Solid Tumours (RECIST), v. 1.1

    All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to respnse evaluation

    Measured: Response of treatment is evaluated according to the RECIST criteria at the end of chemotherapyassessed up to 24 weeks

  3. Toxicity Profile defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03

    Treatment-emergent adverse events, drug-related adverse events and safety laboratory parameters will be analysed by CTCAE grade

    Measured: every 4 cycles of chemotherapy (each cycle is 15 days), up to 16 weeks

  4. Angiogenetic factors levels concentration before and during treatment.

    Angiogenetic factors levels concentration (VEGF, PlGF, HGF, VEGF-R, IL8, IL1a, T-cad, VEGFR3, SAP, VDBP, neuropilin1, CRP, endoglin plasma concentrations)

    Measured: evaluated before treatment and before each cycle (each cycle is 15 days) according to an ELISA-based technique, through completion, an overage of 1 year

Timeline

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

  1. First posted5 Feb 2020
  2. Study start23 Apr 2018
  3. Primary completionApr 2020 (estimated)
  4. Study completionFeb 2021 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Biologically enriched phase II clinical trial. All patients will receive aflibercept in combination with FOLFIRI according to the Italian label.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04252456
Sponsor's protocol ID
2017-002219-33
Other IDs
2017
Acronym
DISTINCTIVE
Status last verified
Jan 2020
First submitted
28 Jan 2020
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan in people with Advanced Colorectal Cancer, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 16 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 17 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Silvia Rota, DM (+39 02 84968409, centrotrialgiscad@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) according to VEGFR2 levels, evaluating the difference in terms of median OS among patients with high VEGFR2 activity and patients with low VEGFR2 activity (time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 3 years). 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 NCT04252456.

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 5 Feb 2020.

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