Phase II study on the use of the FOLFIRI + Cetuximab association in the first-line treatment of patients with advanced colorectal carcinoma with wild type RAS and FcYRIIIA-V / V

Phase II study on the use of the FOLFIRI + Cetuximab association in the first-line treatment of patients with advanced colorectal carcinoma with wild type RAS and FcYRIIIA-V / V - CIFRA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003778-29-IT

Enrollment

Registered

2019-01-14

Start date

2019-03-06

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced colorectal carcinoma with wild type RAS and FcyRIIIA-V / V

Interventions

Trade Name: Erbitux Product Name: Erbitux - Cetuximab Pharmaceutical Form: Emulsion for infusion Trade Name: Campto - Irinotecan Product Name: Irinotecan Pharmaceutical Form: Solution for infusion T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Cytological or histological diagnosis of colorectal adenocarcinoma • wild-type RAS • Fc?RIIIa-158V / V genotype • Stage IV • Negative pregnancy test where applicable • Age 3 months • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria: • Previous systemic anti-tumor treatment; allowed treatment with Capecitabine or fluorouraciol and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated for at least 6 months. • Presence of primary non-treated stenosing colorectal neoplasm with endoprosthesis positioning • Neutrophils 1.5 times the maximum normal value • GOT and / or GPT> 5 times the maximum normal value and / or bilirubinemia> 3 times the maximum normal value • Previous malignant neoplasm (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix) • Infection in active or uncontrolled phase • Other concomitant disorders that are decompensated or uncontrolled or that contraindicate the study drugs at the judgment of the clinician • Presence of brain metastases • Refusal or inability to provide informed consent • Impossibility to guarantee follow-up

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Evaluation of the response after 3 months of therapy and thereafter every 3 months until progression.;Secondary Objective: Secondary objectives: Describe the duration of the response, the progression-free survival (Progression-Free Survival, PFS) and survival (Overall Survival, OS). Evaluate the presence of M1 / M2 macrophages in the tumor microenvironment and correlate it with the response to therapy. Evaluate the toxicity that will be measured with the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.;Main Objective: Main objective: The aim of the present study is to evaluate the activity of the Cetuximab, Irinotecan and Fluorouracil association in patients with metastatic colorectal cancer selected through the study of RAS and of the genetic polymorphism of the Fc?RIIIa V / V;Primary end point(s): To evaluate if the administration of FOLFIRI / Cetuximab is active in the treatment of the 1st line of patients with metastatic colorectal cancer RAS wt and Fc?RIIIA V / V. The answer will be evaluated with the RECIST v1.1.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Evaluation of the response after 3 months of therapy and thereafter every 3 months until progression.;Secondary Objective: Secondary objectives: Describe the duration of the response, the progression-free survival (Progression-Free Survival, PFS) and survival (Overall Survival, OS). Evaluate the presence of M1 / M2 macrophages in the tumor microenvironment and correlate it with the response to therapy. Evaluate the toxicity that will be measured with the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.;Main Objective: Main objective: The aim of the present study is to evaluate the activity of the Cetuximab, Irinotecan and Fluorouracil association in patients with metastatic colorectal cancer selected through the study of RAS and of the genetic polymorphism of the Fc?RIIIa V / V;Primary end point(s): To evaluate if the administration of FOLFIRI / Cetuximab is active in the treatment of the 1st line of patients with metastatic colorectal cancer RAS wt and Fc?RIIIA V / V. The answer will be evaluated with the RECIST v1.1.

—

Secondary

Measure	Time frame
Secondary end point(s): Describe the duration of the response, progression-free survival (Progression-Free Survival, PFS) and survival (Overall Survival, OS). Evaluate the presence of M1 / M2 macrophages in the tumor microenvironment and correlate it with the response to therapy. Evaluate the toxicity that will be measured with the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.;Timepoint(s) of evaluation of this end point: Evaluation of the response after 3 months of therapy and thereafter every 3 months until progression.	—

Measure

Time frame

Secondary end point(s): Describe the duration of the response, progression-free survival (Progression-Free Survival, PFS) and survival (Overall Survival, OS). Evaluate the presence of M1 / M2 macrophages in the tumor microenvironment and correlate it with the response to therapy. Evaluate the toxicity that will be measured with the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.;Timepoint(s) of evaluation of this end point: Evaluation of the response after 3 months of therapy and thereafter every 3 months until progression.

—

Countries

Italy

Contacts

Public ContactAlessandro Ottaiano

Istituto Nazionale Tumori G. Pascale

a.ottaiano@istitutotumori.na.itItaly0815903367

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026