Overview

This trial is active, not recruiting.

Condition colorectal cancer metastatic
Treatments cetuximab, irinotecan
Phase phase 2
Target EGFR
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date January 2015
End date September 2016
Trial size 2 participants
Trial identifier NCT02316496, REGAIN C13-2

Summary

The main objective of this study is to evaluate the objective response rate at two months (complete disappearance of the disease and partial disappearance of the disease) obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer.

Secondaries objectives will be assessed progression-free survival, overall survival, toxicity, quality of life.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cetuximab - irinotecan until progression or unacceptable toxicity
cetuximab
cetuximab 500mg/m²/ IV infusion, (q2w)
irinotecan
Irinotecan 180mg/m², in 500ml NaCl 0.9% solution, 90 min IV infusion (q2w)

Primary Outcomes

Measure
Objective response rate (ORR)
time frame: At 2 months

Secondary Outcomes

Measure
Objective response rate (ORR)
time frame: up to 27 months
Disease control rate (DCR)
time frame: up to 27 months
Progression-free survival (PFS)
time frame: up to 27 months
Duration of response (DOR)
time frame: up to 27 months
Time to response (TTR)
time frame: up to 27 months
Time to progression (TTP)
time frame: up to 27 months
Time to treatment failure (TTF)
time frame: up to 27 months
Duration of stable disease (DoSD)
time frame: up to 27 months
Overall survival (OS)
time frame: up to 27 months
Adverse Events (CTCAE v.4.03)
time frame: Up to 27 months
Quality of life
time frame: Up to 27 months
Respose rate
time frame: up to 27 months
PFS
time frame: up to 27 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Signed and dated informed consent - Histologically confirmed metastatic adenocarcinoma of the colon or rectum - All Wild Type KRAS (exon 2 [codons 12-13], exon 3 [codons - 61]; exon 4 [codon 146]), NRAS (exon 2 [ codons 12-13] and exon 3 [codon 61) and BRAF (V600E) tumor ( local assessment performed either on primary tumor or metastasis) - First line chemotherapy regimen with a fluoropyrimidine and Irinotecan (FOLFIRI) + cetuximab with initial partial or complete response and progressive disease (PD) with PD ≤ 6 weeks after the last administration of cetuximab - Other line(s) of therapy(ies) including the following drugs: second line oxaliplatin based chemotherapy with fluoropyrimidines (5FU or capecitabine) + bevacizumab and eventually regorafenib (possible but not mandatory) and progression or limiting toxicity to the last therapy with a minimum of 4 months between last injection of cetuximab and inclusion in this study - At least one measurable lesion ≥ 10 mm as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1 (All sites must be evaluated ≤ 28 days prior to the enrolment) - Age ≥18 years - World Health Organization (WHO) Performance status (PS) 0-2 - The patient has adequate organ function, defined as : Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL, and platelets ≥ 100 x 109/L.Total bilirubin ≤ 1.5 times upper limit of normal value (ULN), serum alkaline phosphatase level < 5 times ULN, Serum creatinine level <150μM/l - For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study drug - Men and women are required to use adequate birth control during the study (when applicable) and until 6 months after the end of study treatment - Registration in a national health care system (CMU included) Exclusion Criteria: - Previous chemotherapy other than adjuvant therapy with different combinations than those scheduled in first and second line treatment - Presence of any KRAS, BRAF or NRAS mutation by allelic discrimination on tumor DNA - Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiation of study treatment or a history of ventricular arrhythmia (treated or not) - History or evidence of central nervous system metastasis (systematic CT-scan or MRI not mandatory if no clinical symptoms) - Known allergy or hypersensitivity to cetuximab - Previous or concurrent malignancy except for basal or squamous cell skin cancer, in situ carcinoma of the cervix, low-risk prostate cancer according to d'Amico classification or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to the study - Active or uncontrolled clinically serious infection - Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness - Other serious and uncontrolled non-malignant disease - Pregnancy - Breast feeding - Treatment with any other investigational medicinal product within 28 days prior to study entry - Known Gilbert's syndrome - Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine - Concomitant use with St John's Wort - Chronic inflammatory bowel disease and/or Bowel obstruction

Additional Information

Official title A Phase II Study of Cetuximab Rechallenge in Combination With Irinotecan in Advanced Metastatic Colorectal Cancer Without KRAS or NRAS or BRAF Mutation (All Wild Type) for Patients Pretreated With FOLFIRI and Cetuximab in First Line With Stopping Cetuximab for Progressive Disease After a Previous Response (Partial Response or Complete Response) and After Treatment With a Fluoropyrimidine, Oxaliplatin Plus Bevacizumab Regimen
Principal investigator Jean Marc GORNET, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR).