Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, the investigators assessed the effect of Cetuximab in combination with chemotherapy in the treatment of unresectable metastatic colorectal cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xu jianmin
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;

2. Primary tumour has undergone radical resection and histologically confirmed colorectal adenocarcinoma;

3. Together with clinical or radiological evidence of first occurrence of non-resectable synchronous liver-only metastases

4. With evidence of tumor EGFR expression and KRAS gene wild-type status;

5. With one measurable tumor.

6. Performance status (ECOG) 0~1

7. A life expectancy of ≥ 3 months

8. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)

9. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);

10. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases.

2. Known or suspected extrahepatic metastases.

3. Patients with known hypersensitivity reactions to any of the components of the study treatments.

4. Having previously participated in a study which included a possibility of being allocated to cetuximab therapy (whether or not the patient actually received cetuximab)

5. Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal

6. Acute or sub-acute intestinal occlusion

7. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding

8. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

9. Known drug abuse/ alcohol abuse

10. Legal incapacity or limited legal capacity

11. Pre-existing peripheral neuropathy.