Status and phase
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About
This is a multicentric, phase II and open label study.75 patients are expected to be randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS metastatic colorectal cancer.
Full description
Patients who will sign the inform consent will be enrolled into one of two groups. Group A will receive Afatinib ( 40mg per day) and Cetuximab (500mg/m2)every two weeks until progression. Group B will receive Cetuximab (500mg/m2) alone every two weeks until progression and after progression,patients from group B will receive afatinib (group A treatment) until progression. The criteria for evaluation will be tumor response and progression documented by CT scan and according to RECIST criteria version 1.1.
Patient will also sign a inform consent before participating in biological study. The aim of this translational study is to collect tumor and blood sample in order to determine, the biological factors which are predictive of the response to treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Metastatic colorectal cancer expressing the wtKRAS status
No previous EGFR targeted therapy.
Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease
Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)
Life expectancy of at least 3 months.
Patient with ECOG ≤ 1
Patients aged ≥ 18.
Patient with measurable lesions according to RECIST criteria (version 1.1) with spiral CT scan and defined as ≥ 10 mm in longest diameter and 2X the slice thickness for extra nodal lesions and/or > 15 mm in short axis diameter for nodal lesions
Patient able to receive adequate oral nutrition of ≥ 1500 calories per day and free of significant nausea and vomiting
Patient with adequate organ function:
Adequate contraception if applicable.
Ability to take oral medication in the opinion of the investigator
Patient able and willing to comply with study procedures as per protocol
Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
Patient affiliated to a social security regimen
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
75 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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