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New treatment option for Colorectal Cancer
Official title Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
ClinicalTrials.gov ID: NCT03874026
What this study is testing
What is Folfiri/Cetuximab?
Folfiri/Cetuximab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patients' selection thorough the identification of predictive factors still represent a challenge in metastatic colorectal cancer (mCRC). Cetuximab (Erbitux®), a chimeric monoclonal antibody binding to the Epidermal Growth Factor Receptor (EGFR), belongs to the Immunoglobulins (Ig) grade 1 subclass able to elicit both in vitro and in vivo the Antibody-Dependent Cell-mediated Cytotoxicity (ADCC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Cytological or histological diagnosis of colorectal adenocarcinoma;
- KRAS, NRAS, BRAF wild-type;
- FcγRIIIaV/V genotype;
- stage IV;
- age \<75 years;
You likely can't join if
- previous systemic anti-tumor treatment (allowed treatment with capecitabine or fluorouracil and radiotherapy in the neoadjuvant setting of rectal...
- 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...
- previous malignant neoplasms (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix);
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.