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

NCT02980510 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: UCGI 28 PANIRINOX2016-001490-33
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 6

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

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

  12 months after inclusion

Study Arms (2)

A=Experimental group

EXPERIMENTAL

FOLFIRINOX + Panitumumab oxaliplatin 85 mg/m² IV infusion over 2 hours immediately followed by folinic acid 400 mg/m² given as a 2-hour intravenous (IV) infusion with the addition, after 30 minutes of irinotecan 150 mg/m² given as a 90-minute intravenous infusion through a Y-connector immediately followed by fluorouracil 400 mg/m² IV bolus then 5-fluoruracil (5-FU) 2400 mg/m² over 46 hours continuous infusion.

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

B=Control group

ACTIVE COMPARATOR

mFOLFOX6 + Panitumumab mFOLFOX6 every 2 weeks: oxaliplatin 85 mg/m² IV infusion over 2 hours immediately followed by folinic acid 400 mg/m² IV infusion over 2 hours followed by fluorouracil 400 mg/m² IV bolus then 5-FU 2400 mg/m² over 46 hours continuous infusion.

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

Interventions

Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil DRUG

B=Control group

Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan DRUG

A=Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Calcemia \<2mmol/L
• Patient with known dihydropyrimidine dehydrogenase deficiency

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (6)

Institut Sainte Catherine

Avignon, France

Location

Centre Léon Berard

Lyon, France

Location

Chu Saint Eloi

Montpellier, France

Location

ICM Val D'Aurelle

Montpellier, France

Location

Institut de Cancérologie de Lorraine

Nancy, France

Location

CHU Carémeau - Institut de Cancérologie du Gard

Nîmes, France

Location

Related Publications (1)

• Pisareva E, Mihalovicova L, Pastor B, Kudriavtsev A, Mirandola A, Mazard T, Badiou S, Maus U, Ostermann L, Weinmann-Menke J, Neuberger EWI, Simon P, Thierry AR. Neutrophil extracellular traps have auto-catabolic activity and produce mononucleosome-associated circulating DNA. Genome Med. 2022 Nov 28;14(1):135. doi: 10.1186/s13073-022-01125-8.

  PMID: 36443816 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab; Oxaliplatin; Leucovorin; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids

Study Officials

• Thibault MAZARD

  ICM VAL D'AURELLE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The primary endpoint is the complete response rate where complete response is defined as complete disappearance of metastatic lesions after a maximum of 12 cycles of chemotherapy and tumor marker level normalization (CEA).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 2, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
• Access Criteria: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.

Locations

FR (6)