FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation

Metastatic Colorectal Cancer Clinical Trial

— OPTIPRIME  

Official title:

A Phase II Study Evaluating FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03584711
• Other study ID #: FFCD 1605
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 26, 2018
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-arm, multi-centre phase II study The primary objective is to evaluate the time to failure of the strategy.

Description:

The purpose of the OPTIPRIME phase II non-randomised study is to evaluate the efficacy and tolerability of the combination of FOLFOX plus panitumumab according to a "stop and go" strategy. If disease control is achieved while on induction treatment, oxaliplatin and panitumumab will be stopped after the sixth cycle; a maintenance treatment of fluoropyrimidine alone will be continued. In case of progression during maintenance treatment, oxaliplatin and panitumumab reintroduction loops will take place according to the same regimen (maintenance treatment after six cycles of the reintroduced therapy if disease control is achieved).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• - Histologically proven colorectal adenocarcinoma without RAS mutation

• Confirmed, non-resectable metastatic disease (Stage IV)

• No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months

• At least one measurable metastasis according to the RECIST v1.1 criteria

• Age = 18 years

• WHO = 2

• Neutrophils > 1500 /mm3, platelets> 100 000/mm3, Hb > 9 g/dL

• Creatinine clearance > 50 mL/min according to the MDRD formula

• Serum bilirubin < 25 µmol/L, AST, ALT, Alk Phos < 2.5 x ULN or < 5 x ULN in case of liver metastases

• PT > 60%, albumin = 25g/L

• Estimated life expectancy = 3 months

• Patient affiliated to a social security scheme

• Patient informed and informed consent form signed

Exclusion Criteria:

• - Presence of uncontrolled symptomatic brain metastases

• RAS mutation (KRAS or NRAS mutation)

• Patient taking warfarin. If treated with anticoagulant at the indicated effective dose, this must be replaced with low molecular weight heparin before inclusion

• Known DPD deficiency

• Peripheral neuropathy > 1 (NCI CTCAE v4.0)

• Patient with interstitial pneumonitis or pulmonary fibrosis

• History of chronic diarrhoea or inflammatory disease of the colon or rectum, or obstruction or sub-obstruction during symptomatic treatment

• Poorly controlled chronic skin disease

• Any known specific contraindication or allergy to the medicinal products used in the study

• Patient simultaneously included in another clinical trial involving an investigational drug (example: chemotherapy, targeted therapy, immunotherapy)

• Arterial hypertension not controlled by medical treatment (Systolic BP = 160 mmHg end/or diastolic BP = 90 mmHg)

• Any progressive pathology not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure

• The following conditions in the 6 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischaemic attack

• Patient who has received a transplant, is seropositive for HIV, hepatitis B or hepatitis C or has other immunodeficiency syndromes

• History of malignant pathologies during the past 5 years except basal cell carcinoma of the skin or cervical carcinoma in situ, properly treated

• QT/QTc interval > 450 msec for men and > 470 msec for women

• K+ < LNL, Mg2+ < LNL, Ca2+ < LNL

• Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age who have not had a pregnancy test

• Persons in custody or under wardship

• Impossibility of undergoing medical monitoring during the trial for geographical, social or psychological reasons

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Colorectal Cancer

Intervention

Combination Product:
• FOLFOX + panitumumab
FOLFOX + panitumumab according to a "stop and go" strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment

Locations

Country	Name	City	State
France	Clinique Claude Bernard	Albi
France	Clinique de L'Europe	Amiens
France	Hopital Sud	Amiens
France	Chu D'Angers	Angers CEDEX 9
France	Hopital Prive D'Antony	Antony
France	Centre Marie Curie	Arras
France	Hopital Les Bonnettes	Arras CEDEX
France	Ch Cote Basque	Bayonne CEDEX
France	Ch de Beauvais	Beauvais
France	Ch de Beziers Cedex	Béziers
France	Polyclinique Saint Privat	Boujan-sur-Libron
France	Cmco Cote D'Opale	Boulogne-sur-Mer
France	Hopital Duchenne	Boulogne-sur-Mer
France	Hopital Morvan - Chu	Brest
France	Centre Francois Baclesse	Caen
France	Ch Cahors	Cahors
France	Centre Hospitalier General	Châlons-en-Champagne
France	Ch de Cholet	Cholet
France	Hopitaux Civils de Colmar	Colmar
France	Service de Medecine	Digne-les-Bains
France	CH	Dunkerque CEDEX 01
France	Hopital Jacques Monod	Flers CEDEX
France	Chi de Frejus Saint-Raphael	Fréjus
France	Polyclinique de Blois - 3Eme Etage	La Chaussee St Victor
France	Chd Vendee	La Roche-sur-Yon
France	Ch Du Mans	Le Mans CEDEX 9
France	Centre Hospitalier Schaffner	Lens
France	Chru Hopital Claude Huriez 4Eme Est	Lille
France	Ch St Joseph-St Luc	Lyon
France	Hopital Europeen Marseille	Marseille
France	Ch de Meaux	Meaux
France	Hopital Layne	Mont-de-Marsan
France	Polyclinique de Gentilly	Nancy
France	Hopital Prive Du Confluent Sas	Nantes
France	Ch de Niort - Sce D'Oncologie	Niort CEDEX
France	Chu Cochin	Paris
France	Groupe Hospitalier Pitie-Salpetriere	Paris
France	Groupe Hospitalier Pitie-Salpetriere	Paris CEDEX 13
France	Polyclinique de Courlancy	Reims
France	Centre Hospitalier	Saint-Quentin CEDEX
France	Clinique Trenel	Sainte Colombe	Lyon
France	Centre Paul Strauss	Strasbourg
France	Clinique Ste Anne	Strasbourg
France	Polyclinique de L'Ormeau	Tarbes
France	Clinique Pasteur	Toulouse
Martinique	Chu de Fort de France	Fort-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive	Amgen

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to failure of the strategy	Time to strategy Failure is defined as the time from date of inclusion to strategy failure (Radiological progression under treatment or death or definitive treatment discontinuation or recurrence after curative surgery with or without adjuvant treatment)	Up to 20 months