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

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ClinicalTrials.gov Identifier: NCT02980510
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief 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.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Panitumumab, oxaliplatin, folinic acid, 5fluoruracil Drug: Panitumumab, oxaliplatin, folinic acid, 5fluoruracil, irinotecan Phase 2

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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A=Experimental group
FOLFIRINOX + 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.
Drug: Panitumumab, oxaliplatin, folinic acid, 5fluoruracil, irinotecan
Active Comparator: B=Control group
mFOLFOX6 + 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.
Drug: Panitumumab, oxaliplatin, folinic acid, 5fluoruracil



Primary Outcome Measures :
  1. Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab. [ Time Frame: 12 months after inclusion ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT02980510


Contacts
Contact: Veronica Pezzella +33 1 44 23 04 77 v-pezzella@unicancer.fr
Contact: Marie Bergeaud m-bergeaud@unicancer.fr

Locations
France
Institut Sainte Catherine Not yet recruiting
Avignon, France
Contact: Laurent MINEUR       l.mineur@isc84.org   
Principal Investigator: Laurent MINEUR, Dr         
Centre Léon Berard Not yet recruiting
Lyon, France
Contact: Christelle DE LA FOUCHARDIERE       christelle.delafouchardiere@lyon.unicancer.fr   
Principal Investigator: Christelle DE LA FOUCHARDIERE, Dr         
Chu Saint Eloi Not yet recruiting
Montpellier, France
Contact: Eric ASSENAT       e-assenat@chu-montpellier.fr   
Principal Investigator: Eric ASSENAT, Dr         
ICM Val D'Aurelle Recruiting
Montpellier, France
Contact: Thibault MAZARD       Thibault.Mazard@icm.unicancer.fr   
Principal Investigator: Thibault MAZARD, Dr         
Institut de Cancérologie de Lorraine Not yet recruiting
Nancy, France
Contact: Céline GAVOILLE       c.gavoille@nancy.unicancer.fr   
Principal Investigator: Céline GAVOILLE, Dr         
CHU Carémeau - Institut de Cancérologie du Gard Not yet recruiting
Nimes, France
Contact: Stéphane OBLED       stephane.obled@chu-nimes.fr   
Principal Investigator: Stéphane OBLED, Dr         
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Thibault MAZARD ICM VAL D'AURELLE

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02980510     History of Changes
Other Study ID Numbers: UCGI 28 PANIRINOX
2016-001490-33 ( EudraCT Number )
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Antibodies, Monoclonal
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients