NCT00070265

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

A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

PRIMARY OBJECTIVES: I. Determine the efficacy and toxicity of neoadjuvant and adjuvant capecitabine and oxaliplatin in patients with resectable liver metastases secondary to colorectal cancer who are undergoing surgery. II. Determine the rates of R0 resection in patients treated with this regimen before surgery. SECONDARY OBJECTIVES: I. Determine the response rate in patients treated with this regimen. II. Determine the resectability in the subsets of patients defined as resectable preoperatively and treated with this regimen. III. Determine improvement in survival associated with downstaging based on metastatic colorectal prognostic score in patients treated with this regimen. IV. Determine the disease-free and overall survival of patients treated with this regimen. V. Correlate drug-specific biomarkers with clinical response in patients treated with this regimen. OUTLINE: This is a multicenter study. Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Surgery: Four to six weeks after the completion of chemotherapy, patients undergo surgical resection of the tumor. Adjuvant chemotherapy: Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery. Patients are followed at 4-6 weeks after surgery, every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study.

Conditions

• Liver Metastases
• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin	Given IV
DRUG	capecitabine	Given orally
PROCEDURE	therapeutic conventional surgery	Undergo surgical resection
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2003-08-01
• Primary completion: 2004-09-01
• First posted: 2003-10-07
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States