FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progr… (NCT03584711) | Clinical Trial Compass
CompletedPhase 2
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
France118 participantsStarted 2018-04-26
Plain-language summary
Single-arm, multi-centre phase II study The primary objective is to evaluate the time to failure of the strategy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 anot…
What they're measuring
1
Time to failure of the strategy
Timeframe: Up to 20 months
Trial details
NCT IDNCT03584711
SponsorFederation Francophone de Cancerologie Digestive