Randomized, open-label phase II study evaluating the safety and efficacy of Cetuximab plus modified FOLFOX - 6 versus modified FOLFOX - 6 alone as 2nd line therapy after progression on the 1st line treatment with Cetuximab + FOLFIRI in patients with metastatic colorectal cancer KRAS wild-type – TAGUS Study - TAGUS Study
- Conditions
- Colorectal cancer KRAS wild-type
- Registration Number
- EUCTR2008-008282-36-PT
- Lead Sponsor
- Grupo de Investigação do Cancro Digestivo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br><br>To assess the combination safety profile.
- Secondary Outcome Measures
Name Time Method