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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 (OPTIPRIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03584711
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 26, 2019
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Combination Product: FOLFOX + panitumumab Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arm Intervention/treatment
Experimental: FOLFOX + panitumumab

1 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

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

Primary Outcome Measures :
  1. Time to failure of the strategy [ Time Frame: Up to 20 months ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03584711

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Contact: lila gaba 0380393483
Contact: jeremie bez 0380393483

Show Show 46 study locations
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
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Principal Investigator: Jean-Baptiste Bachet, Pr Federation Francophone de Cancerologie Digestive

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Responsible Party: Federation Francophone de Cancerologie Digestive Identifier: NCT03584711    
Other Study ID Numbers: FFCD 1605
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federation Francophone de Cancerologie Digestive:
Stop and Go strategy
RAS Wild-type
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents