Clinical trial NCT02404935: Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
Official title: Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic colorectal cancer
cetuximab
maintenance
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed colorectal cancer
2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
3. Non resectable metastatic disease in a curative intent
4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion
5. At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated
6. Life expectancy above 3 months
7. Performance Status ≤2 (WHO)
8. Patient ≥18 years-old
9. Acceptable blood test
10. Patient having signed a written informed consent form

Exclusion Criteria:

1. Known and/or symptomatic brain metastases
2. Known allergy to one of treatment components
3. Neurological or psychiatric condition which could interfere with good treatment compliance
4. Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
5. Other severe conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization
7. Concomitant severe infection
8. History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
9. Patient already included in another clinical trial with an investigational molecule
10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
11. Pregnant female, likely to be or currently breastfeeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
12. Those deprived of their freedom or under guardianship
13. Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons

Primary outcomes:
measure: Progression Free Survival at 6 months
timeFrame: 6 months after start of maintenance therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Ile De France
city: Amiens
country: France
facility: CHU- Hôpital Sud
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Auxerre
country: France
facility: Centre Hospitalier d'Auxerre
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bayonne
country: France
facility: Centre Hospitalier Intercommunal Cote Basque
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Blois
country: France
facility: Centre Hospitalier de Blois
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: Clinqiue Tivoli
city: Bordeaux
country: France
facility: Institut Bergonie
city: Béziers
country: France
facility: Centre Hospitalier de Béziers
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: Hôpital Côte de nacre
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougier
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougier
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Estaing
city: Dijon
country: France
facility: Hôpital du Bocage
city: Draguignan
country: France
facility: Centre Hospitalier de la Dracénie
city: Evry
country: France
facility: Clinique du Mousseau
city: Frejus
country: France
facility: Centre Hospitalier Intercommunal
city: La Roche-sur-Yon
country: France
facility: Centre hospitalier Départemental de Vendée - Les Oudairies
city: La Seyne-sur-Mer
country: France
facility: Clinique du Cap d'Or
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Clinique Francois Chenieux
city: Limoges
country: France
facility: CHU de Limoges - Hôpital Dupuytren
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Hôpital Privé Clairval
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montelimar
country: France
facility: Centre Hospitalier Montelimar
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier - Clinique Clementville
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Orléans
country: France
facility: Centre Hospitalier d'Orléans La Source
city: Perigueux
country: France
facility: Polyclinique Francheville
city: Perpignan
country: France
facility: Hôpital Saint Jean
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: CHU - Robert Debre
city: Romans
country: France
facility: Centre Hospitalier de Romans
city: Roubaix
country: France
facility: Centre Hospitalier Hôpital Victor Provo
city: Saint Gregoire
country: France
facility: Hôpital Saint Gregoire
city: Saint Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Saint-Priest-en-Jarez
country: France
facility: CHU Saint Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Valérie Boige, Dr
role: PRINCIPAL_INVESTIGATOR
References: