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

NCT04252456 | Unknown

• 1 other identifier: 2017-002219-33
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 16

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

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (4)

• 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

  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

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

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

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

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

• Angiogenetic factors levels concentration before and during treatment.

  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

Study Arms (1)

standard chemotherapy for advanced colorectal cancer

OTHER

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

Procedure: Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan

Interventions

Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan PROCEDURE

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

standard chemotherapy for advanced colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• Known dihydropyrimidine dehydrogenase deficiency
• Treatment with CYP3A4 inducers unless discontinued \> 7 days prior to First Study treatment.
• 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

Sponsors & Collaborators

• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente: lead

Study Sites (16)

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

Treviglio, Bergamo, 24047, Italy

ACTIVE NOT RECRUITING

A.O. Humanitas Gavazzeni

Bergamo, BG, 24125, Italy

RECRUITING

Policlinico Universitario D.Casula

Monserrato, Cagliari, 09121, Italy

RECRUITING

A.O. Polo Oncologico Vito Fazzi

Lecce, LE, 73100, Italy

NOT YET RECRUITING

ASST-Rhodense

Rho, Milano, 20017, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, MI, 20133, Italy

RECRUITING

AUSL di Piacenza

Piacenza, PC, 29100, Italy

RECRUITING

Centro Riferimento

Aviano, PN, 33081, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera San Carlo

Potenza, PZ, 85100, Italy

RECRUITING

Ospedale Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

Fondazione Poliambulanza, Via Bissolati 57

Brescia, 25100, Italy

RECRUITING

IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

ACTIVE NOT RECRUITING

IRCCS Istituto Europeo di Oncologia

Milan, 20141, Italy

ACTIVE NOT RECRUITING

A.O.U. Policlinico di Modena

Modena, 41124, Italy

RECRUITING

A.O. S.Giovanni Calabita Fatebenefratelli

Roma, 00186, Italy

ACTIVE NOT RECRUITING

Ospedale San Bortolo

Vicenza, 36100, Italy

RECRUITING

MeSH Terms

Interventions

aflibercept; Fluorouracil

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Silvia Rota, DM

CONTACT

+39 02 84968409; centrotrialgiscad@yahoo.it

Eleonora Lai, DM

CONTACT

+39 392 2886023; sperimentazioniclinicheunica@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All patients will receive aflibercept in combination with FOLFIRI according to the Italian label.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Biologically enriched phase II clinical trial. All patients will receive aflibercept in combination with FOLFIRI according to the Italian label.

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: April 23, 2018
• Primary Completion: April 1, 2020
• Study Completion: February 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

IT (16)