Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement
Stopped early · Phase 2
Conditions studied: Colorectal Cancer, Metastases
In brief
The purpose of this study is to determine the effect of short-duration pre-operative FOLFOX based therapy on postoperative problems after liver surgery for patients with metastatic colorectal cancer.
Key facts
- Study ID
- NCT00537823
- Run by
- Washington University School of Medicine
- People needed
- 9
- Starts
- 2007-06-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2016-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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