The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis. Further Objectives: 1. Development of acneiforme follicular exanthema \>= grade 2 2. Duration until development of acneiforme follicular exanthema \>= grade 2 3. Development of paronychia 4. Development skin fissure (hand and foot) 5. Objective remission according RECIST 1.1 6. Rate of secondary resections of liver metastasis with a curative approach 7. Assessment of safety and tolerability 8. Overall survival 9. Progression free survival
Subjects with metastatic colorectal cancer and confirmed KRAS-wildtype status in 1st line therapy will be included in this phase IV-study. Subject will receive a regimen of FOLFIRI in combination with Cetuximab every two weeks during study treatment phase. Treatment continues until * disease progression * complete response * development of status of operability * an uncontrollable exanthema grade 3 or 4 or * intolerable toxicity is diagnosed. After study discontinuation or end of treatment, respectively, patients will be followed up until the the last patient was treated for 12 months and has completed the 36-months follow up phase. Tumor response will be evaluated (according to RECIST 1.1) every 12 weeks and at the end of study treatment
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
165
1. Cetuximab (Erbitux® )- Cetuximab is a recombinant IgG1 chimeric monoclonal antibody directed against human epidermal growth factor receptor (EGFR). 2. FOLFIRI regimen Administration Schedule: Cetuximab at a initial dose 400 mg/sqm (first week), then 250 mg/sqm on day 1 and 8 Background Chemotherapy (every two weeks) * Irinotecan 180 mg/m² iv , 90 min on day 1 * Folic acid (racemic) 400 mg/m², 120 min on day 1 * 5-FU 400 mg/m² bolus on day 1 * 5-FU 2400 mg/m² iv over 46 h on day 1 to 2
Universitätsmedizin Mainz
Mainz, Germany
Progression-free survival
Progression-free survival rate at 12 months
Time frame: 12 months
Progression-free survival
Time frame: up to end of follow-up-phase (36 months)
ORR
Objective response rate over the entire treatment period
Time frame: approximately 12 months
OS
Overall survival time
Time frame: The time from regsitration date to the date of death
Duration until development of acneiforme follicular exanthema >= grade 2
Duration until development of acneiforme follicular exanthema \>= grade 2 during treatment-phase
Time frame: approximately 12 months
Development of paronychia
Development of paronychia during treatment-phase
Time frame: approximately 12 months
Development of skin fissure (hand and foot)
Development of skin fissure (hand and foot) during treatment-phase
Time frame: approximately 12 months
Rate of secondary resections of metastasis of liver with a curative approach
Rate of secondary resections of metastasis of liver with a curative approach during treatment-phase
Time frame: approximately 12 months
Assessment of safety and tolerability
Assessment of safety and tolerability during treatment phase
Time frame: approximately 12 months
Development of acneiforme follicular exanthema >= grade2
Development of acneiforme follicular exanthema \>= grade2 during treatment phase
Time frame: approximately 12 months
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