Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)

Metastatic Colorectal Cancer Clinical Trial

— TIME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404935
• Other study ID #: Prodige 28 - UCGI 27 (TIME)
• Secondary ID: 2012-005139-99
• Status: Completed
• Phase: Phase 2
• Start date: November 22, 2013
• Est. completion date: October 25, 2021

Study information

• Verified date: March 2022
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 25, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Cetuximab

• FOLFIRI and cetuximab

Locations

Country	Name	City	State
France	CHU- Hôpital Sud	Amiens
France	Centre Hospitalier Universitaire d'Angers	Angers
France	Centre Hospitalier d'Auxerre	Auxerre
France	Institut Sainte Catherine	Avignon
France	Centre Hospitalier Intercommunal Cote Basque	Bayonne
France	Centre Hospitalier de Beauvais	Beauvais
France	Centre Hospitalier de Béziers	Béziers
France	Centre Hospitalier de Blois	Blois
France	Hôpital Avicenne	Bobigny
France	Clinqiue Tivoli	Bordeaux
France	Institut Bergonie	Bordeaux
France	Centre François Baclesse	Caen
France	Hôpital Côte de nacre	Caen
France	Centre Hospitalier Jean Rougier	Cahors
France	Centre Hospitalier Jean Rougier	Cahors
France	Centre Hospitalier Estaing	Clermont-Ferrand
France	Hôpital du Bocage	Dijon
France	Centre Hospitalier de la Dracénie	Draguignan
France	Clinique du Mousseau	Evry
France	Centre Hospitalier Intercommunal	Frejus
France	Centre hospitalier Départemental de Vendée - Les Oudairies	La Roche-sur-Yon
France	Clinique du Cap d'Or	La Seyne-sur-Mer
France	Hôpital Bicêtre	Le Kremlin Bicêtre
France	Centre Oscar Lambret	Lille
France	CHU de Limoges - Hôpital Dupuytren	Limoges
France	Clinique Francois Chenieux	Limoges
France	Centre Léon Bérard	Lyon
France	Hôpital Privé Clairval	Marseille
France	Institut Paoli Calmettes	Marseille
France	Centre Hospitalier Montelimar	Montelimar
France	Centre de Cancérologie du Grand Montpellier - Clinique Clementville	Montpellier
France	Institut régional du Cancer Montpellier	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Centre Hospitalier d'Orléans La Source	Orléans
France	Polyclinique Francheville	Perigueux
France	Hôpital Saint Jean	Perpignan
France	Centre Hospitalier Lyon Sud	Pierre Bénite
France	CHU - Robert Debre	Reims
France	Centre Hospitalier de Romans	Romans
France	Centre Hospitalier Hôpital Victor Provo	Roubaix
France	Hôpital Saint Gregoire	Saint Gregoire
France	Clinique Mutualiste de l'Estuaire	Saint Nazaire
France	CHU Saint Etienne - Hôpital Nord	Saint-Priest-en-Jarez
France	Centre Paul Strauss	Strasbourg
France	Polyclinique de l'Ormeau	Tarbes
France	Centre Hospitalier Intercommunal de Toulon	Toulon
France	Gustave Roussy	Villejuif	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival at 6 months	Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause	6 months after start of maintenance therapy