A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX6 + Cetuximab versus FOLFIRI + Cetuximab as first-line therapy in patients with metastatic colorectal cancer

Conditions: first-line therapy in patients with metastatic colorectal cancer

Registration Number: EUCTR2004-002391-42-HU

Lead Sponsor: CECOG (Central European Cooperative Oncology Group)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

•Signed written informed consent
•Male or female more or equal 18 years of age
•Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
•Metastatic colorectal carcinoma not suitable for curative-intent resection
•Availability of tumor sample (or able and willing to provide tumor sample)
for EGFR assessment
•Presence of at least one lesion measurable unidimensionally by CT scan or MRI. (Target lesion(s) must not lie within an irradiated area)
•ECOG performance status less than 2
•White blood cell count more or equal 3.0 x 109/L with neutrophils more or equal 1.5 x 109/L, platelet count more or equal 100 x 109/L, and hemoglobin more or equal 9 g/dL.
•Bilirubin level either normal or less or equal 1.5 x ULN
•ASAT and ALAT less or equal 2.5 x ULN (less or equal 5 x ULN if liver metastasis are present)
•Serum creatinine less or equal 1.5 x ULN

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

•Brain metastasis (known or suspected)
•Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months.
•Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
•Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
•Any investigational agent(s) within 4 weeks prior to entry
•Previous exposure to EGFR-pathway targeting therapy
•Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
•Acute or subacute intestinal occlusion or history of inflammatory bowel disease
•Pre-existing neuropathy > grade 1
•Known grade 3 or 4 allergic reaction to any of the components of the treatment.
•Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for more or equal 5 years will be allowed to enter the trial)
•Pregnancy or lactation
•Inadequate contraception (male or female patients) if of childbearing or procreational potential
•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 patient to complete the study or sign meaningful informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method