unresectable and/or metastatic colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who have unresectable and/or metastatic colorectal adenocarcinoma with KRAS wild type, history of progression of disease of 5-FU based chemotherapy as the first-line during the treatment or within 6 months after the last administration of the regimen, measurable lesion according to the RECIST version1.1, Eastern Cooperative Oncology Performance Status of 0-2, adequate major organ function and can comprehend and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients who have central nervous system metastasis, homozygote of UGT1A1 *28 or *6, double heterozygote of UGT1A1 *28 and *6, prior anti-EGFR therapy, unresolved toxicities from prior anthi-cancer therapy, clinically significant complication, pre- or co-existing interstitial pneumoniae, do not consent to use adequate contraceptive precausions with child-bearing potential, are breast-feeding or pregnant female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence rates and timing of grade two or more skin toxicity during 6 weeks from Panitumumab contained chemotherapy started. | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, disease control rate, progression free survival, overall survival, any adverce event, sebum cutaneum measurment and stratum corneum hydration measurment from Panitumumab contained chemotherapy started. | — |
Countries
Japan