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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT02980510
• Date of registration: 30/11/2016
• Prospective Registration: Yes
• Primary sponsor: UNICANCER
• Public title: Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients PANIRINOX
• Scientific 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
• Date of first enrolment: December 2016
• Target sample size: 219
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02980510
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Thibault MAZARD
• Affiliation: ICM VAL D'AURELLE

Key inclusion & exclusion 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

12. Uracilemia < 16 ng/ml

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 LLN

- 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. Participation in another therapeutic 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metastatic Colorectal Cancer

Intervention(s)

Drug: Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan

Drug: Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil

Primary Outcome(s)

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

Secondary ID(s)

UCGI 28 PANIRINOX

2016-001490-33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors