Status:
ACTIVE_NOT_RECRUITING
CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Metastatic Colorectal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX, irinotecan) in mCRC p...
Detailed Description
Based on dynamic and longitudinal liquid biopsy assessment of RAS/BRAF status, that will be prospectively performed before each line of treatment, mCRC patients will be treated with cetuximab in combi...
Eligibility Criteria
Inclusion
- Histologically proven diagnosis of colorectal adenocarcinoma
- Diagnosis of metastatic disease
- RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis
- Measurable disease according to Response Evaluation Criteria in Solid Tumors RECIST criteria, vers.1.1)
- Male or female patients ≥ 18 years of age
- ECOG Performance Status 0,1
- Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters:
- Bone marrow:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥ 100 x 109/L
- Liver function:
- • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and ALT (SGPT) ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN
- Renal function:
- • Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
- 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 (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 3 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate
- Signed informed consent obtained before screening.
Exclusion
- Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic acid,bevacizumab, trifluridine-tipiracil, regorafenib
- Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease
- Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix
- Pregnancy (exclusion to be ascertained by a beta hCG test)
- Breastfeeding
- Fertile women (\<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception•
- Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification)
- 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 the 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
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2026
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT05312398
Start Date
July 15 2021
End Date
August 15 2026
Last Update
May 25 2025
Active Locations (25)
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1
A.O.U. Ospedali Riuniti
Ancona, AN, Italy
2
Ente Ecclesiastico Ospedale Generale Regionale 'F. Miulli'
Acquaviva delle Fonti, BA, Italy
3
IRCCS Istituto Tumori 'Giovanni Paolo II'
Bari, BA, Italy
4
Ospedale IRCCS 'Saverio de Bellis'
Castellana Grotte, BA, Italy