CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen

  • STATUS
    Recruiting
  • End date
    Jun 15, 2026
  • participants needed
    200
  • sponsor
    University of Campania "Luigi Vanvitelli"
Updated on 27 April 2022

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 patients, whose tumors remain RAS/BRAF WT. The study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status.

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 combination with chemotherapy throughout three lines of therapy, as follows: FOLFIRI plus cetuximab (first line); FOLFOX plus cetuximab (second line); irinotecan plus cetuximab (third line) in case of RAS/BRAF WT at each time point of progression. If at progression after the first line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with FOLFOX plus bevacizumab as the second line of therapy. If at progression after the second line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with regorafenib or trifluridine-tipiracil (investigator's choice), as third line of therapy. Each treatment will be administered using standard doses and schedules until progression of disease or unacceptable toxicity.

This study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with FOLFOX plus bevacizumab, having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status

Details
Condition Metastatic Colorectal Adenocarcinoma
Treatment Cetuximab, Irinotecan, FOLFIRI, FOLFOX regimen
Clinical Study IdentifierNCT05312398
SponsorUniversity of Campania "Luigi Vanvitelli"
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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