Evaluation of the standard therapy with FOLFIRI + Cetuximab until disease progression compared to FOLFIRI + Cetuximab for 8 cycles followed by Cetuximbab until disease progression in first line treatment of patients with RAS and BRAF wild type metastatic colorectal cancer.

Phase 1

• Conditions: Patients with unresectable RAS and BRAF wild-type metastatic colorectal cancer.; MedDRA version: 17.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004299-41-IT
• Lead Sponsor: Dipartimento di Scienze Mediche Oncologia Medica Policlinico Gemelli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-11
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

- Histologically proven diagnosis of colorectal adenocarcinoma;
- Diagnosis of metastatic disease;
- RAS and BRAF wild-type;
- Measurable disease according to RECIST criteria v1.1;
- Male or female pts > 18 years of age;
- ECOG Performance Status = 2;
- Life expectancy of at least 3 months;
- Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment;
- If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment;
- If female and of childbearing potential, or if male, agreement to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method);
- Signed informed consent obtained at screening.
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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Any contraindication to use cetuximab, irinotecan, 5-FU or folinic acid
- Active uncontrolled infections or active disseminated intravascular coagulation
- Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- Pregnancy.
- Breastfeeding.
- Grade III or IV heart failure (NYHA classification)
- Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study
- Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
- Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
- Previous chemotherapy for colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
- Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
- Known or clinically suspected brain metastases
- History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
- Severe, non-healing wounds, ulcers or bone fractures
- Uncontrolled hypertension
- Marked proteinuria (nephrotic syndrome)
- Known DPD deficiency (specific screening not required)
- Known history of alcohol or drug abuse
- A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
- Absent or restricted legal capacity

Study & Design

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