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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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).

Study Groups

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A=Experimental group

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

B=Control group

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.

Group Type ACTIVE_COMPARATOR

Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil

Intervention Type DRUG

Interventions

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Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No