Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement
Colorectal Cancer, Metastases
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Metastasis, Neoadjuvant Therapy
Eligibility Criteria
Inclusion Criteria:
- Synchronous or metachronous colorectal metastases
Technically resectable liver metastases
- Four or fewer metastases
- No tumors in porta hepatis
- Resection of no more than 70% of liver needed
- Medically suitable candidate for major liver resection
- FDG-PET scan without metastatic disease outside the liver
Exclusion Criteria:
- Near-obstructing or obstructing colon lesions in patients in whom combined resection is planned (as delay for preoperative chemotherapy would be medially impossible)
- Treatment with FOLFOX or cetuximab within 12 months
- Treatment with irinotecan within 12 months
- Abnormal liver function (ALT or AST > 5x ULN, bilirubin > 3x ULN)
- Body mass index >/= 35 kg/m² (as the risk for steatohepatitis is increased)
- Renal insufficiency (Cr > 2.5mg/dL)
- Interstitial lung disease (because cetuximab has been rarely associated with development of interstitial lung disease)
- ECOG performance score >/= 3
- Patients unable to give informed consent
- Pregnant patient (as cetuximab is a Class C drug)
- Peripheral neuropathy >/= grade II (as oxaliplatin causes neuropathy to worsen)
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm 1 - Wildtype
Arm 2 K-Ras 12/13 codon mutation
Neoadjuvant therapy Week 1 Leucovorin 400 mg/m^2 IV Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV 5FU bolus 400 mg/m^2 5FU CIVI 1200 mg/m^2/day over 46 hours Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly Weeks 3, 5, 7 Leucovorin 400 mg/m^2 IV Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV 5FU bolus 400 mg/m^2 5FU CIVI 1200 mg/m^2/day over 46 hours Wait 3-8 weeks after completion of therapy Liver resection Wait 4 weeks or until clinical status allows Adjuvant Therapy Week 1, 3, 5, 7, 9, 11, 13, 15 Leucovorin 400 mg/m^2 IV Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV 5FU bolus 400 mg/m^2 5FU CIVI 1200 mg/m^2/day over 46 hours Weeks 2, 4, 6, 8, 10, 12, 16 *Cetuximab 250 mg/m^2 IV weekly
Neoadjuvant Therapy Weeks 1, 3, 5 Leucovorin 400 mg/m^2 IV Oxaliplatin 85 mg/m^2 IV Bevacizumab 5 mg/kg IV 5FU bolus 400 mg/m^2 5FU CIVI 1200 mg/m^2 Week 7 Leucovorin 400 mg/m^2 IV Oxaliplatin 85 mg/m^2 IV 5FU bolus 400 mg/m^2 5FU CIVI 1200 mg/m^2 Wait 3-8 weeks after completion of therapy Liver resection Wait 4 weeks or until clinical status allows Adjuvant Therapy Weeks 1, 3, 5, 9, 11, 13 Leucovorin 400 mg/m^2 IV Oxaliplatin 85 mg/m^2 IV Bevacizumab 5 mg/kg IV 5FU bolus 400 mg/m^2 5FU CIVI 1200 mg/m^2 Week 7, 15 Leucovorin 400 mg/m^2 IV Oxaliplatin 85 mg/m^2 IV 5FU bolus 400 mg/m^2 5FU CIVI 1200 mg/m^2