Erbitux MEtastatic Colorectal Cancer Strategy Study

NCT02484833 | Completed Phase 3 DMC

• 1 other identifier: 2014-004299-41
• Study Type: interventional
• Target: 607
• Locations: 1 country
• Sites: 1

Brief Summary

• To investigate whether cetuximab alone (given until progression or cumulative toxicity) after 8 cycles of FOLFIRI + cetuximab results in a non inferior Progression Free Survival when compared with continuous FOLFIRI + cetuximab (given until progression or cumulative toxicity).
• To assess whether an improvement in the incidence of grade 3-4 hematological and non-hematological adverse events (AEs) can be achieved in the experimental arm (cetuximab alone after 8 cycles FOLFIRI + cetuximab) as compared to the continuous chemotherapy arm (FOLFIRI plus cetuximab)
• To explore the possibility of using liquid biopsies for molecular profiling as well as monitoring treatment activity in mCRC pts receiving cetuximab based therapy

Conditions

Antineoplastic Agents

Keywords

First line; metastatic colorectal cancer; Cetuximab; strategy study

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  PFS

  every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Incidence of grade 3-4 AEs

  AEs

  weekly from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Secondary Outcomes (6)

• Response rate

  every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Early tumor shrinkage assessed by Response rate at week 8

  at 8 weeks

• Overall survival

  every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Cetuximab-related skin toxicity by CTCAE

  weekly from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Safety profile assessed by CTCAE

  weekly until from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Study Arms (2)

FOLFIRI + Cetuximab until disease progression

ACTIVE COMPARATOR

FOLFIRI + Cetuximab until disease progression

Drug: Cetuximab; Drug: FOLFIRI

FOLFIRI + Cetuximab followed by Cetuximab alone

EXPERIMENTAL

FOLFIRI + Cetuximab for 8 cycles followed by Cetuximab alone until disease progression

Drug: Cetuximab; Drug: FOLFIRI

Interventions

Cetuximab DRUG

FOLFIRI + Cetuximab followed by Cetuximab alone; FOLFIRI + Cetuximab until disease progression

FOLFIRI DRUG

FOLFIRI + Cetuximab followed by Cetuximab alone; FOLFIRI + Cetuximab until disease progression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven diagnosis of colorectal adenocarcinoma
• Diagnosis of metastatic disease
• RAS and BRAF wildtype
• Measurable disease according to RECIST criteria v1.1
• Male or female over 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
• Signed informed consent obtained at screening

You may not qualify if:

• 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)
• 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
• 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)

Sponsors & Collaborators

• Armando Orlandi: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Related Publications (1)

• Pinto C, Orlandi A, Normanno N, Maiello E, Calegari MA, Antonuzzo L, Bordonaro R, Zampino MG, Pini S, Bergamo F, Tonini G, Avallone A, Latiano TP, Rosati G, Cogoni AA, Ballestrero A, Zaniboni A, Roselli M, Tamberi S, Barone C. Fluorouracil, Leucovorin, and Irinotecan Plus Cetuximab Versus Cetuximab as Maintenance Therapy in First-Line Therapy for RAS and BRAF Wild-Type Metastatic Colorectal Cancer: Phase III ERMES Study. J Clin Oncol. 2024 Apr 10;42(11):1278-1287. doi: 10.1200/JCO.23.01021. Epub 2024 Jan 5.

  PMID: 38181312 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Ph.D

Study Record Dates

• First Submitted: April 26, 2015
• First Posted: June 30, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

IT (1)