EUCTR2008-008282-36-PTActive, not recruitingNot Applicable
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
Grupo de Investigação do Cancro Digestivo0 sitesStarted: November 5, 2009Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •- 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
Investigators
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