Colorectal cancer KRAS wild-type
Conditions
Sponsors
Grupo de Investigação do Cancro Digestivo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed written informed consent - Male or Female with, at least, 18 years old - Histologically or cytologically-proven metastatic adenocarcinoma of the colon or rectum with wild-type KRAS status - Patients treated in 1st line treatment with cetuximab + FOLFIRI - Metastatic disease (M1) not amenable to potentially curative treatment - Presence of at least one unidimensionally measurable lesion with a diameter = 20 mm by conventional CT or magnetic resonance imaging (MRI) or = 10 mm by spiral CT (Target lesion(s) must not lie within an irradiated area) - Life expectancy of at least 3 months - ECOG performance status of 0 or 1 at study entry - Effective contraception for both male and female with reproductive potential while on treatment and for 6 months after study treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous chemotherapy for 1st line metastatic CRC other than FOLFIRI + cetuximab - Brain metastases and/or leptomeningeal disease (known or suspected) - FOLFOX adjuvant treatment within 6 months prior to randomization - Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study - Concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception - Patients that had stopped the 1st line cetuximab treatment for other reasons than PD or surgery for metastasis resection - Any concurrent malignancy other than non-melanoma cancer of the skin, or pre-invasive cancer of the cervix. (Patients with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the study). - Grade = 2 neuropathy - Pregnancy (absence to be confirmed by beta-HCG test) or lactation period - Clinically relevant coronary artery disease or history of myocardial infarction in previous 12 months, or high risk of uncontrolled arrhythmia - Known drug abuse or alcohol abuse - Legal incapacity or limited legal capacity - Medical or psychological condition, which, in the opinion of the Investigator, would not permit the patient to complete the study or sign meaningful informed consent - Participation in another clinical study within 30 days before inclusion to this study - Significant disease which, in the Investigator's opinion, would exclude the patient from the study - Known hypersensitivity to any of the trial treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Response rate (RR);Main Objective: This trial’s main objective is to assess the efficacy and safety of cetuximab plus FOLFOX in patients with advanced colorectal cancer that have progressed after 1st line treatment with cetuximab + FOLFIRI;Secondary Objective: To assess the overall survival and time to disease progression in patients with advanced colorectal cancer, KRAS wild-type treated with cetuximab plus modified FOLFOX 6 versus modified FOLFOX 6 alone in patients who have progressed after a 1st line treatment with cetuximab + FOLFIRI. To assess the combination safety profile. | — |
Countries
Portugal
Outcome results
None listed