Resumen

Se trata de un estudio exploratorio para comparar la actividad y la seguridad en 400 pacientes con carcinoma de colon metastásico no tratado previamente, tratados con UFOX (un régimen de combinación de UFT® [tegafur más uracilo], oxaliplatino y ácido folínico) más cetuximab o FOLFOX-4 (un régimen de combinación de 5-fluorouracilo [5-FU], oxaliplatino y ácido folínico) más cetuximab.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Signed written informed consent
Inpatient or outpatient ≥ 18 years of age
Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
First occurrence of metastatic disease (not curatively resectable)
Presence of at least one lesion measurable uni dimensionally by computerised tomography (CT) scan or magnetic resonance imaging (MRI). (Target lesion(s) must not lie within an irradiated area)
Life expectancy of ≥ 3 months
Karnofsky performance status of ≥ 60, at study entry
White blood cell count (WBC) ≥ 3 x 10\^9/L, with neutrophils ≥ 1.5 x 10\^9/L, platelets ≥ 100 x 10\^9/L, and hemoglobin ≥ 9 g/dL
Aspartate transaminase and alanine transaminase ≤ 2.5 x Upper Limit of Normal (ULN) (≤ 5 x ULN if liver metastasis are present)
Normal serum creatinine (in case of elevated creatinine, labelled ethylenediaminetetraacetic acid clearance ≥ 65 mL/min is acceptable)
Effective contraception for both male and female subjects if the risk of conception exists
Tumor biopsy or archived sample available

Criterios de exclusión

Brain metastasis and/or leptomeningeal disease (known or suspected)
Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment.
Previous oxaliplatin-based chemotherapy
Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization
Concurrent or previous chronic systemic immune therapy, targeted therapy, anti-vascular epithelial growth factor (VEGF) therapy, epidermal growth factor receptor (EGFR) pathway targeting therapy not indicated in the study protocol
Concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception
Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
Peripheral neuropathy \>grade 1
Known hypersensitivity reaction to any of the components of the treatment.
Any concurrent malignancy other than basal cell cancer of the skin, or pre-invasive cancer of the cervix. (Subjects with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the study)
Pregnancy (absence to be confirmed by ß-human chorionic gonadotrophin test) or lactation period
Known drug abuse/alcohol abuse
Legal incapacity or limited legal capacity
Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
Participation in another clinical study within the 30 days before randomization
Significant disease which, in the investigator's opinion, would exclude the subject from the study

Intervenciones

drug

UFOX + Cetuximab

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks) * Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21 * Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21

drug

FOLFOX4 + Cetuximab

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks) * 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16 * Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16

Estudio Exploratorio de Fase II, Aleatorizado, Abierto, que Evalúa la Eficacia y Seguridad de FOLFOX-4 más Cetuximab Versus UFOX más Cetuximab como Terapia de Primera Línea en Sujetos con Cáncer Colorrectal Metastásico.