A Phase 2 interventional study of oxaliplatin and capecitabine in Liver Metastases, Recurrent Colon Cancer and Recurrent Rectal Cancer, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2013-01-24.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 80 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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Inclusion Criteria:
Histologically confirmed hepatic colorectal metastasis by percutaneous hepatic biopsy
Resectable disease, as determined by a surgeon with hepatic surgery expertise (at least 10 resections performed per year)
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.
Drug: oxaliplatin · Drug: capecitabine · Procedure: therapeutic conventional surgery · Other: laboratory biomarker analysis
Given IV
Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Given orally
Also known as: CAPE, Ro 09-1978/000, Xeloda
Undergo surgical resection
Correlative studies
Rate of complete resection (R0 resection)
The design of Thall and Simon will be used.
Time frame: Up to 5 years
Response rate assessed using RECIST criteria
Time frame: Up to 5 years
Resectability in the subsets defined as resectable preoperatively
Time frame: Up to 5 years
Improvement in survival associated with downstaging based on metastatic colorectal prognostic score
Time frame: Up to 5 years
Disease-free survival
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Positron emission tomography response rate
Time frame: Up to 5 years
This study is terminated, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)