Clinical Trials /

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

NCT02980510

Description:

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.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients
  • Official Title: Phase II Randomized Study Comparing FOLFIRINOX + Panitumumab Versus mFOLFOX6 + Panitumumab in Metastatic Colorectal Cancer Patients Selected by RAS and B-RAF Status From Circulating DNA Analysis

Clinical Trial IDs

  • ORG STUDY ID: UCGI 28 PANIRINOX
  • SECONDARY ID: 2016-001490-33
  • NCT ID: NCT02980510

Conditions

  • Metastatic Colorectal Cancer

Interventions

DrugSynonymsArms
Panitumumab, oxaliplatin, folinic acid, 5fluoruracilB=Control group
Panitumumab, oxaliplatin, folinic acid, 5fluoruracil, irinotecanA=Experimental group

Purpose

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.

Detailed 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 v 4.03 classification)

        -  Diagnostic performance of ccfDNA analysis compared to the tumor-tissue analysis (current
           gold standard)
    

Trial Arms

NameTypeDescriptionInterventions
A=Experimental groupExperimentalFOLFIRINOX + Panitumumab oxaliplatin 85mg/m² IV infusion over 2 hours immediately followed by folinic acid 400mg/m² given as a 2-hour IV infusion with the addition, after 30 minutes of irinotecan 150mg/m² given as a 90-minute intravenous infusion through a Y-connector immediately followed by fluorouracil 400mg/m² IV bolus then 5-FU 2400 mg/m² over 46 hours continuous infusion.
  • Panitumumab, oxaliplatin, folinic acid, 5fluoruracil, irinotecan
B=Control groupActive ComparatormFOLFOX6 + Panitumumab mFOLFOX6 every 2 weeks: oxaliplatin 85mg/m² IV infusion over 2 hours immediately followed by folinic acid 400mg/m² IV infusion over 2 hours followed by fluorouracil 400mg/m² IV bolus then 5-FU 2400mg/m² over 46 hours continuous infusion.
  • Panitumumab, oxaliplatin, folinic acid, 5fluoruracil

Eligibility Criteria

        Inclusion Criteria:

          1. Age between 18 and 75 years

          2. ECOG PS between 0 and 1

          3. Histologically confirmed adenocarcinoma of the colon or rectum

          4. Untreated synchronous or metachronous metastatic disease deemed unresectable with
             curative intent

          5. 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

          6. Measurable disease according to RECIST version 1.1

          7. 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)

          8. Life expectancy of at least 3 months

          9. Adequate contraception if applicable

         10. Patient affiliated to a social security regimen

         11. Patient information and signed written consent form

        Exclusion Criteria:

          1. History of other malignancy within the previous 5 years (except for appropriately
             treated in-situ cervix carcinoma and non-melanoma skin carcinoma)

          2. Adjuvant treatment with oxaliplatin

          3. Previous treatment for metastatic disease

          4. Patients who received any chemo- and/or radiotherapy within 15 days from the date of
             blood sampling for the RAS and BRAF test

          5. Brain metastases

          6. Patients with a history of severe or life-threatening hypersensitivity to the active
             substances or to any of the excipients delivered in this study

          7. Patient with history of pulmonary fibrosis or interstitial pneumonitis

          8. Previous organ transplantation, HIV or other immunodeficiency syndromes

          9. 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…)

         10. Persistent peripheral neuropathy >grade1 (NCI CT v4.03)

         11. Ionic disorders as:

               -  Kalemia ≤1 x ULN

               -  Magnesemia <0.5mmol/L

               -  Calcemia <2mmol/L

         12. Patient with known dihydropyrimidine dehydrogenase deficiency

         13. QT/QTc>450msec for men and >470msec for women

         14. Patient with contraindication for trial drugs (investigators have to refer to SmPC
             drugs, see Appendix 7)

         15. Concomitant intake of St. John's wort

         16. Other concomitant cancer

         17. Patient participating another clinical trial

         18. Pregnant woman or lactating woman

         19. Patients with psychological, familial, sociological or geographical condition
             hampering compliance with the study protocol and follow-up schedule

         20. Legal incapacity or limited legal capacity
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.
Time Frame:12 months after inclusion
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:UNICANCER

Last Updated