Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients (PANIRINOX)

  • STATUS
    Recruiting
  • End date
    Jan 2, 2024
  • participants needed
    209
  • sponsor
    UNICANCER
Updated on 24 February 2022
measurable disease
fluorouracil
metastasis
oxaliplatin
neutrophil count
panitumumab
leucovorin
irinotecan
adenocarcinoma
folfirinox
adenocarcinoma of colon
modified folfox6

Summary

National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis.

Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.

Description

PRIMARY OBJECTIVE: Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab

SECONDARY OBJECTIVE(S):

  • Overall Survival
  • Progression free survival
  • Secondary resection
  • Early tumor shrinkage (ETS)
  • Depth of response (DpR)
  • Safety profile (NCI-CTCAE v4.03 classification)
  • Diagnostic performance of ccfDNA analysis compared to the tumor-tissue analysis (current gold standard)

Details
Condition Metastatic Colorectal Cancer
Treatment Panitumumab, oxaliplatin, folinic acid, 5fluoruracil, Panitumumab, oxaliplatin, folinic acid, 5fluoruracil, irinotecan, Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan
Clinical Study IdentifierNCT02980510
SponsorUNICANCER
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 18 and 75 years
ECOG PS between 0 and 1
Histologically confirmed adenocarcinoma of the colon or rectum
Untreated synchronous or metachronous metastatic disease deemed unresectable with curative intent
K-Ras (codons 12, 13, 59, 61, 117, 146), N-Ras (codons 12, 13, 59, 61) and B-Raf (codon 600) wild-type tumor status according to plasma analysis of circulating cell free DNA by Intplex technology
Measurable disease according to RECIST version 1.1
Adequate hematologic, hepatic and renal functions
Absolute neutrophil count (ANC) 2 x 109/L
Haemoglobin 9 g/dL
Platelets (PTL) 100 x 109/L
AST/ALT 5 x ULN
Alkaline phosphatase 2.5 x ULN
Bilirubin 1.5 x ULN
Creatinine clearance 50 mL/min (Cockcroft and Gault formula)
Life expectancy of at least 3 months
Adequate contraception if applicable
Patient affiliated to a social security regimen
Patient information and signed written consent form
Uracilemia < 16 ng/ml

Exclusion Criteria

History of other malignancy within the previous 5 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
Adjuvant treatment with oxaliplatin
Previous treatment for metastatic disease
Patients who received any chemo- and/or radiotherapy within 15 days from the date of blood sampling for the RAS and BRAF test
Brain metastases
Patients with a history of severe or life-threatening hypersensitivity to the active substances or to any of the excipients delivered in this study
Patient with history of pulmonary fibrosis or interstitial pneumonitis
Previous organ transplantation, HIV or other immunodeficiency syndromes
Concomitant medications/comorbidities that may prevent the patient from receiving study treatment as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, inflammatory bowel disease, intestinal obstruction, symptomatic congestive heart failure, uncontrolled hypertension)
Persistent peripheral neuropathy >grade1 (NCI CT v4.03)
Ionic disorders as
Kalemia 1 x LLN
Magnesemia <0.5mmol/L
Patient with known dihydropyrimidine dehydrogenase deficiency
Calcemia <2mmol/L
QT/QTc>450msec for men and >470msec for women
Concomitant intake of St. John's wort
Patient with contraindication for trial drugs (investigators have to refer to SmPC drugs, see Appendix 7)
Other concomitant cancer
Pregnant woman or lactating woman
Participation in another therapeutic trial
Patients with psychological, familial, sociological or geographical condition hampering compliance with the study protocol and follow-up schedule
Legal incapacity or limited legal capacity
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