Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study

NCT02316496 | Terminated Phase 2

• 1 other identifier: REGAIN C13-2
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Colorectal Cancer Metastatic

Keywords

Cancer; Colorectal; Metastatic; Thrid-line; Irinotecan; Cetuximab

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  At 2 months

Secondary Outcomes (13)

• Objective response rate (ORR)

  up to 27 months

• Disease control rate (DCR)

  up to 27 months

• Progression-free survival (PFS)

  up to 27 months

• Duration of response (DOR)

  up to 27 months

• Time to response (TTR)

  up to 27 months

Study Arms (1)

open label , single arm

EXPERIMENTAL

cetuximab - irinotecan until progression or unacceptable toxicity

Drug: cetuximab; Drug: Irinotecan

Interventions

cetuximab DRUG

cetuximab 500mg/m²/ IV infusion, (q2w)

open label , single arm

Irinotecan DRUG

Irinotecan 180mg/m², in 500ml NaCl 0.9% solution, 90 min IV infusion (q2w)

open label , single arm

Eligibility Criteria

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

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (20)

Hôpital Beaujon

Clichy, France

Location

Centre hospitalier Alpes Leman

Contamine-sur-Arve, France

Location

Centre Georges François Leclerc

Dijon, France

Location

CHD Vendée

La Roche/ Yon, France

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

Hôpital Européeen

Marseille, France

Location

Institut Paoli-Calmettes

Marseille, France

Location

CHU Caremeau

Nîmes, France

Location

CHU Cochin

Paris, France

Location

Hôpital Pitié Salpêtrière

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Hôpital Saint Louis

Paris, France

Location

Hôpital Tenon

Paris, France

Location

Clinique Armoricaine de Radiologie

Saint-Brieuc, France

Location

Groupe hospitalier Public du Sud de l'Oise -site de Senlis

Senlis, France

Location

Centre de radiothérapie - Clinique Sainte Anne

Strasbourg, France

Location

Hôpital Foch

Suresnes, France

Location

Hôpitaux du Léman

Thonon-les-Bains, France

Location

CHU Tours - Hôpital Trousseau

Tours, France

Location

Clinique Générale

Valence, France

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Cetuximab; Irinotecan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Jean Marc GORNET, MD

  Hôpital Saint Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 15, 2014
• Study Start: September 23, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-01

Locations

FR (20)