A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX4 + weekly Cetuximab versus FOLFOX4 + bi-weekly Cetuximab as first-line therapy in patients with K-ras wild-type metastatic colorectal cancer

Conditions: first-line therapy in patients with metastatic colorectal cancer and K-ras wild type
MedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

Registration Number: EUCTR2006-006941-15-GR

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 at least 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 K-ras and EGFR assessment; K-ras has to be assessed asWild-type” by a central laboratory
• Presence of at least one lesion measurable unidimensionally by CT scan or MRI (target lesion(s) must not lie within an irradiated area)
• Karnofsky performance status of > 80 at study entry
• Leucocytes at least 3.0 x 109/L and neutrophils at least 1.5 x 109/L, platelets at least 100 x 109/L, and hemoglobin at least 9 g/dL
• Bilirubin not exceeding 1.5 x ULN
• ASAT and ALAT not exceeding 2.5 x ULN (not exceeding 5 x ULN if liver metastasis are present)
• Serum creatinine not exceeding 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 disease. Prior adjuvant chemotherapy 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. In case of prior oxaliplatin containing adjuvant chemotherapy: pre-existing neuropathy of grade 1 or higher.
• 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 at least 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