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 1

• Conditions: advanced colorectal carcinoma with wild type RAS and FcyRIIIA-V / V; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003778-29-IT
• Lead Sponsor: Istituto Nazionale Tumori G. Pascale

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-14
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 34

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 <75 years
• At least 1 lesion measurable according to the RECIST criteria v1.1
• ECOG Performance Status 0 or 1
• Life expectancy> 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

• 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 <2000 / mm³ or platelets <100,000 / mm³ or hemoglobin <9 g / dl
• Creatinineemia> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified