Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer

Stopped early · Phase 2

Conditions studied: Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

In brief

Drugs used in chemotherapy, such as capecitabine and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Giving capecitabine and oxaliplatin before surgery may shrink the tumor so that it can be removed. Giving capecitabine and oxaliplatin after surgery may kill any remaining tumor cells. This phase II trial is studying how well capecitabine and oxaliplatin work when given before and after surgery in treating patients with resectable liver metastases that is secondary to colorectal cancer

Key facts

Study ID: NCT00070265
Run by: National Cancer Institute (NCI)
People needed: 80
Starts: 2003-08-01
Last updated by the study team: 2013-01-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed hepatic colorectal metastasis by percutaneous hepatic biopsy
Imaging evidence of liver metastasis by CT helical scan
Resectable disease, as determined by a surgeon with hepatic surgery expertise (at least 10 resections performed per year)
Resectable, defined as a sparing of 2 adjacent liver segments with adequate vascular inflow and outflow and hepatic remnant volume
Minor resections (less than a hemihepatectomy) or major resections (hemihepatectomy or extended hepatectomy) allowed
Bilobar resection allowed, including atypical resections
No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis
Performance status - Zubrod 0-1
WBC at least 3,000/mm\^3
Absolute neutrophil count at least 1,500/mm\^3
Platelet count at least 100,000/mm\^3
Hemoglobin at least 9.0 g/dL
Bilirubin no greater than 2 mg/dL
AST and ALT no greater than 300 IU/L
No preexisting chronic hepatic disease (e.g., chronic active hepatitis or cirrhosis) that would preclude surgical resection of metastases
Creatinine no greater than 1.5 mg/dL
Creatinine clearance 60 mL/min
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
No preexisting grade 2 or greater peripheral neuropathy

Where it is running

University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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