Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first

Detailed Description
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The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC. EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively. Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.

Official Title
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A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
* Drug: FOLFOX 6
* Drug: FOLFIRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum Metastatic colorectal carcinoma not suitable for curative-intent resection Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area) ECOG performance status of < 2 at study entry Exclusion Criteria: Brain metastasis (known or suspected) Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any investigational agent(s) within 4 weeks prior to entry Previous exposure to EGFR-pathway targeting therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FOLFOX 6<br>FOLFOX 6: Oxaliplatin 100 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks: | Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan<br> <br> Drug: FOLFOX 6<br>* FOLFOX 6: Oxaliplatin 100 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:<br>|
| Active Comparator: FOLFIRI<br>FOLFIRI: Irinotecan 180 mg/m² day 1 concurrent with Leucovorin 400 mg/m² followed by Bolus 5FU 400 mg/m², followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks | Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan<br> <br> Drug: FOLFIRI<br>* FOLFIRI: Irinotecan 180 mg/m² day 1 concurrent with Leucovorin 400 mg/m² followed by Bolus 5FU 400 mg/m², followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of patients surviving without disease progression in each arm at 9 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS rates at 3,6,12 months |  |  | 
| Response rates |  |  | 
| Overall survival (OS) in each arm |  |  | 
| Safety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic colorectal cancer, FOLFOX 6, FOLFIRI