Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients

Launched by NATIONAL CANCER INSTITUTE, NAPLES · Mar 11, 2019

Keywords

ClinConnect Summary

The CIFRA study is investigating a combination treatment for patients with stage IV colorectal cancer, specifically looking at the effects of the drug cetuximab alongside two other medications, irinotecan and fluorouracil. This study focuses on patients with a specific genetic makeup (the FcγRIIIa V/V genotype) who have certain types of tumors that are not mutated in KRAS, NRAS, or BRAF genes. The goal is to see if this genetic factor helps improve the drug's effectiveness by enhancing a process called Antibody-Dependent Cell-mediated Cytotoxicity (ADCC), which is a way the immune system can attack cancer cells.

To be eligible for this study, participants must be under 75 years old, have a confirmed diagnosis of colorectal adenocarcinoma, and have at least one measurable tumor. They should also be in good overall health, with a life expectancy of more than three months. Those interested in participating can expect to be monitored closely throughout the trial to assess how well the treatment works and to track any side effects. The study aims to contribute to a better understanding of how cetuximab works and how it interacts with the immune system, which could lead to improved treatments for colorectal cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Cytological or histological diagnosis of colorectal adenocarcinoma;
• • KRAS, NRAS, BRAF wild-type;
• • FcγRIIIaV/V genotype;
• • stage IV;
• • age \<75 years;
• • at least 1 measurable lesion;
• • ECOG (Eastern Cooperative Oncology Group) Performance Status 0 or 1;
• • life expectancy\> 3 months;
• • negative pregnancy test for all potentially childbearing women;
• • written informed consent.
• Exclusion Criteria:
• • previous systemic anti-tumor treatment (allowed treatment with capecitabine or fluorouracil and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated at least 6 months before);
• • presence of primary non-treated stenosing colorectal neoplasm;
• • neutrophils \<2000/mm³ or platelets \<100.000/mm³ or hemoglobin \<9 g/dl;
• • serum creatinine level\> 1.5 times the maximum normal value;
• • GOT (glutamic oxaloacetic transaminase) and/or GPT (glutamic pyruvic transaminase) \>5 times the maximum normal value and/or bilirubin level \>3 times the maximum normal value;
• • previous malignant neoplasms (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix);
• • active or uncontrolled infections;
• • other concomitant uncontrolled diseases or conditions contraindicating the study - drugs at clinician evaluation;
• • presence of brain metastases;
• • refusal or inability to provide informed consent;
• • impossibility to guarantee follow-up.