resectable liver metastases of colorectal cancer
Conditions
Interventions
Product Name: Cetuximab
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Current Sponsor code: EMD271786
Concentration unit: mg/ml milligram(s)/millili
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -male or female patients with potentially resectable liver metastases from CRC -patients with metachronous or synchronous metastases who have undergone comlete resection (R0) of the primary tumour at least 4 weeks before randomization into the study -no evidence of extra-hepatic disease -patients can be entered in the study irrespective of the EGFR-expression status of their CRC -WHO performance status: 0,1 -age: 18 to 80 years -no previous chemotherapy for metastatic disease -any previous adjuvant chemotherapy for primary cancer is allowed, except for patients who ended an oxaliplatin containing adjuvant treatment less than 12 months ago, and except for patients with persisting neuropathy -no previous exposure to EGFR- or VEGF/VEGFR-targeting therapy -absolute neutrophil count > 1.5 x 109 /L, platelets > 100 x 109/L, hemoglobin > 9 g/dL, and white blood cell count (WBC) > 3 x 109 /L -serum creatinine less than 1.5 times the upper limit of normal (ULN); no significant proteinuria (>500 mg/24 hours urine collection) -written informed consent before randomization according to ICH/EU GCP, and local, national and international regulations 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
Exclusion criteria: - major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to randomization - peripheral neuropathy and serious nonhealing wound, ulcer, or bone fracture - clinically significant cardiovascular disease - pregnancy or breast feeding. Adequate contraception is required for both male and female patienst if the risk of conception exists. Methods of adequate contraception are: condon use with spermicide, hormonal contraception, intra-uterine device - participation in another clinical study within the 30 days before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to evaluate the safety and activity of the administration of an oxaliplatin-fluoropyrimidine regimen (modified FOLFOX6) in combination with either cetuximab alone or with cetuximab plus bevacizumab, as a pre- and post-operative treatment for resectable liver metastases from CRC The trial is a screening phase II trial with 2 investigational regimens. It is planned to further investigate the treatment(s) that are selected to be tolerable and active based on this phase II study in (a) future phase III trial(s) of the EORTC GI group focusing on resectable liver metastases of colorectal origin.;Secondary Objective: ;Primary end point(s): Primary endpoint: Response rate (pre-operative response rate) and safety (rate of peri-operative safety findings) Seconday endpoints: progression-free survival (PFS), pathological resection rate, and overall survival. | — |
Countries
Austria, Belgium, France, Germany, Sweden, United Kingdom
Outcome results
None listed