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)

  • STATUS
    Recruiting
  • End date
    Nov 7, 2024
  • participants needed
    118
  • sponsor
    Federation Francophone de Cancerologie Digestive
Updated on 7 April 2022
serum bilirubin level
metastasis
neutrophil count
panitumumab
fluoropyrimidine
folfox regimen
adenocarcinoma
adjuvant chemotherapy
colorectal adenocarcinoma
metastatic colorectal adenocarcinoma
ras mutation
Accepts healthy volunteers

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).

Details
Condition Metastatic Colorectal Cancer
Treatment FOLFOX + panitumumab
Clinical Study IdentifierNCT03584711
SponsorFederation Francophone de Cancerologie Digestive
Last Modified on7 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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