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Metastatic Colorectal CancerPhase 2OPTIPRIMENCT03584711

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

A Phase 2 study testing FOLFOX + panitumumab in people with Metastatic Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 124 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
FOLFOX + panitumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
124 sitesin 2 countries
Study dates
26 Apr 2018to 30 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • - 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
Show all 13Show fewer
  • 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

Who cannot join

  • - 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
Show all 20Show fewer
  • 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

Trial locations and contacts

124 sites in 2 countries.

124 sites in 2 countries

France123 sites

  • Clinique Claude Bernard

    Albi, 81030

  • Clinique Claude Bernard

    Albi

  • Hopital Sud

    Amiens, 80054

  • Clinique de L'Europe

    Amiens, 80090

  • CHU Amiens Picardie Hôpital Sud

    Amiens

  • Clinique de l'Europe

    Amiens

  • Chu D'Angers

    Angers, 49933

  • CHU

    Angers

  • Hopital Prive D'Antony

    Antony, 92166

  • Hôpital Privé

    Antony

  • Centre Marie Curie

    Arras, 62000

  • Hopital Les Bonnettes

    Arras, 62012

  • Centre Marie Curie

    Arras

  • Hôpital Privé Les Bonnettes

    Arras

  • CH Henri Duffaut

    Avignon

  • Institut Sainte Catherine

    Avignon

  • Ch Cote Basque

    Bayonne, 64109

  • Centre Hospitalier Côte Basque

    Bayonne

  • Ch de Beauvais

    Beauvais, 60021

  • Centre Hospitalier

    Beauvais

  • Ch de Beziers Cedex

    Béziers, 34525

  • Centre Hospitalier

    Béziers

  • Polyclinique Saint Privat

    Boujan-sur-Libron, 34760

  • Cmco Cote D'Opale

    Boulogne-sur-Mer, 62222

  • Hopital Duchenne

    Boulogne-sur-Mer, 62321

  • Hôpital Duchenne

    Boulogne-sur-Mer

  • Hopital Morvan - Chu

    Brest, 29609

  • CHU

    Brest

  • Centre Francois Baclesse

    Caen, 14076

  • Centre François Baclesse

    Caen

  • Ch Cahors

    Cahors, 46000

  • Loire Vendee Ocean

    Challans

  • Centre Hospitalier General

    Châlons-en-Champagne, 51005

  • Centre Hospitalier

    Châlons-en-Champagne

  • Hôpital Louis Pasteur

    Chartres

  • Ch de Cholet

    Cholet, 49325

  • Centre Hospitalier

    Cholet

  • Hopitaux Civils de Colmar

    Colmar, 68024

  • Hôpitaux Civils de Colmar

    Colmar

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes

  • Clinique de Flandre

    Coudekerque-Branche

  • Service de Medecine

    Digne-les-Bains, 04000

  • Centre Hospitalier

    Digne-les-Bains

  • Centre G. François Leclerc

    Dijon

  • CHU

    Dijon

  • CH

    Dunkirk, 59385

  • Centre Hospitalier

    Dunkirk

  • Hopital Jacques Monod

    Flers, 61104

  • CH J Monod

    Flers

  • CHU Martanique Hôpital Clarac

    FORT de France

  • Chi de Frejus Saint-Raphael

    Fréjus, 83600

  • CHI Fréjus St Raphaël

    Fréjus

  • Hôpital Michallon

    Grenoble

  • Polyclinique de Blois - 3Eme Etage

    La Chaussée-Saint-Victor, 41260

  • Polyclinique Blois

    La Chaussée-Saint-Victor

  • Chd Vendee

    La Roche-sur-Yon, 85925

  • CHD VENDEE (Les Oudairies)

    La Roche-sur-Yon

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

  • Ch Du Mans

    Le Mans, 72037

  • Centre Hospitalier

    Le Mans

  • Centre Hospitalier Schaffner

    Lens, 62307

  • Centre Hospitalier

    Lens

  • Chru Hopital Claude Huriez 4Eme Est

    Lille, 59037

  • CHU Claude Huriez

    Lille

  • Hôpital Privé LE BOIS

    Lille

  • Ch St Joseph-St Luc

    Lyon, 69365

  • CH Saint Joseph St Luc

    Lyon

  • Prive - Jean Mermoz

    Lyon

  • Chi F. Quesnay

    Mantes-la-Jolie

  • Hopital Europeen Marseille

    Marseille, 13331

  • Hôpital Européen

    Marseille

  • Ch de Meaux

    Meaux, 77100

  • Centre Hospitalier

    Meaux

  • Hopital Layne

    Mont-de-Marsan, 40024

  • Centre Hospitalier

    Montélimar

  • CHI

    Montfermeil

  • Polyclinique de Gentilly

    Nancy, 54100

  • Centre d'oncologie de Gentilly

    Nancy

  • Hopital Prive Du Confluent Sas

    Nantes, 44277

  • Le Confluent SAS

    Nantes

  • Ch de Niort - Sce D'Oncologie

    Niort, 79021

  • Centre Hospitalier

    Niort

  • CHR

    Orléans

  • Chu Cochin

    Paris, 75014

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75651

  • CHU Bichat

    Paris

  • Groupe Diaconnesses Croix St Simon

    Paris

  • Groupe Hospitalier Pitie-Salpetriere

    Paris

  • HEGP

    Paris

  • Hôpital Cochin (APHP)

    Paris

  • La Pitie Salpetriere

    Paris

  • Centre Hospitalier

    Périgueux

  • Polyclinique Francheville

    Périgueux

  • Hôpital Haut Lévêque

    Pessac

  • CHU

    Poitiers

  • Clinique de la Croix du Sud

    Quint-Fonsegrives

  • Polyclinique de Courlancy

    Reims, 51100

  • Institut du Cancer Courlancy

    Reims

  • CH de Romans

    Romans-sur-Isère

  • Centre Hospitalier

    Roubaix

  • CHU

    Rouen

  • Saint Hilaire - Privee

    Rouen

  • CHP

    Saint-Grégoire

  • Clinique de l'Union

    Saint-Jean

  • Centre Médical Côte d'Opale

    Saint-Martin-Boulogne

  • Hopital Nord Chu Saint Etienne

    Saint-Priest-en-Jarez

  • Centre Hospitalier

    Saint-Quentin, 02321

  • Centre Hospitalier

    Saint-Quentin

  • Clinique Trenel

    Sainte-Colombe, Lyon, 69560

  • Clinique Trenel

    Sainte-Colombe

  • Clinique Charcot

    Sainte-Foy-lès-Lyon

  • Clinique Ste Anne

    Strasbourg, 67000

  • Centre Paul Strauss

    Strasbourg, 67065

  • Centre Paul Strauss

    Strasbourg

  • Clinique Sainte Anne

    Strasbourg

  • Polyclinique de L'Ormeau

    Tarbes, 65000

  • Hôpital Sainte Musse

    Toulon

  • Clinique Pasteur

    Toulouse, 31076

  • Clinique Pasteur

    Toulouse

  • CHRU

    Tours

  • Clinique des Dentellières

    Valenciennes

  • Hôpital Privé

    Villeneuve-d'Ascq

  • Médipôle Hôpital Mutualiste Lyon Villeurbanne

    Villeurbanne

Other trials in France

Martinique1 site

  • Chu de Fort de France

    Fort-de-France, 97261

Other trials in Martinique

About this study

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

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

Read the detailed 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).

Being tested
FOLFOX + panitumumab
Keywords
Stop and Go strategy, RAS Wild-type
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFOX + panitumumabCombination product

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

Study groups in NCT03584711
Study groupRoleWhat they receive
FOLFOX + panitumumabExperimental1 cylce every 14 days : Panitumumab : 6 mg/kg en IV (J1) during 60 minutes for 1st infusion followed by 30 to 60 minutes Oxaliplatine : 85 mg/m² inG5% orNaCl 0.9% in IV (D1) during 2 hours Acide folinique : 400 mg/m² (or200 mg/m² if Elvorine) in IV (D1) 5Fu bolus : 400 mg/m² in IV 5FU continu : 2400 mg/m² in IV during 46 hours LV5FU2 : 1 cycle every 14 days Acide folinique : 400 mg/m² (or 200 mg/m² ifElvorine) in IV (D1) during 2 hours 5FU bolus : 400 mg/m² in IV 5FU continu : 2400 mg/m² in IV during 46 hours
Receives: Combination Product: FOLFOX + panitumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2018
  2. Study start26 Apr 2018
  3. Primary completion30 Mar 2025
  4. Study completion30 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03584711
Sponsor's protocol ID
FFCD 1605
Acronym
OPTIPRIME
Status last verified
Jun 2025
First submitted
19 Jun 2018
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOX + panitumumab in people with Metastatic Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 124 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to failure of the strategy (time frame: Up to 20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03584711.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

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