Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central European Cooperative Oncology Group
• Treatments: Cetuximab; Oxaliplatin

Criteria

Inclusion Criteria:

• Signed written informed consent

• Male or female ≥ 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 ≥ 3.0 x 10 9/L and neutrophils ≥1.5 x 10 9/L, platelets ≥ 100 x 10 9/L, and hemoglobin ≥ 9 g/dL.

• Bilirubin ≥ 1.5 x ULN

• ASAT and ALAT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis are present)

• Serum creatinine ≤ 1.5 x ULN

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 ≥ 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 ≥ 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