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 metastatic colorectal cancer

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

Registration Number: EUCTR2006-006941-15-AT

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 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)
• 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
Main Objective: To assess the efficacy of FOLFOX4 plus weekly cetuximab and FOLFOX4 plus cetuximab every two weeks with respect to the objective response rates as assessed by RECIST criteria, in each arm.;Secondary Objective: To assess the efficacy of both regimens with respect to the percentage of patients surviving without disease progression as assessed by RECIST criteria in each arm, and the overall survival in each arm. <br><br>To evaluate the safety profile of these combinations by recording the adverse events and abnormal laboratory values associated with the study treatments.<br>;Primary end point(s): Objective response (CR/PR), as assessed by RECIST criteria

Secondary Outcome Measures

Name	Time	Method