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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

NCT03584711

Description:

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

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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 IDs

  • ORG STUDY ID: FFCD 1605
  • NCT ID: NCT03584711

Conditions

  • Metastatic Colorectal Cancer

Purpose

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

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).
    

Trial Arms

NameTypeDescriptionInterventions
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

    Eligibility Criteria

            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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:Accepts Healthy Volunteers

    Primary Outcome Measures

    Measure:Time to failure of the strategy
    Time Frame:Up to 20 months
    Safety Issue:
    Description: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)

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Federation Francophone de Cancerologie Digestive

    Trial Keywords

    • Stop and Go strategy
    • RAS Wild-type

    Last Updated