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Home > "N" Clinical Trials Conditions > Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer  Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
For Condition: stage 4 colon cancer,recurrent colon cancer,recurrent rectal cancer,Stage 4 rectal cancer,liver metastases
Status: Not yet recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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. PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant capecitabine and oxaliplatin in treating patients who have resectableliver metastases that is secondary to colorectal cancer.
Details: OBJECTIVES: Primary - 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. - Determine the rates of R0 resection in patients treated with this regimen before surgery. Secondary - Determine the response rate in patients treated with this regimen. - Determine the resectability in the subsets of patients defined as resectable preoperatively and treated with this regimen. - Determine improvement in survival associated with downstaging based on metastatic colorectal prognostic score in patients treated with this regimen. - Determine the disease-free and overall survival of patients treated with this regimen. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - 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 Hepatic - 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 Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - 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 - No concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic therapy - No concurrent sargramostim (GM-CSF) Chemotherapy - More than 6 months since prior adjuvant fluorouracil-based chemotherapy - No prior chemotherapy for liver metastasis - No prior oxaliplatin for colorectal cancer - No prior or concurrent hepatic artery infusion chemotherapy for metastatic disease Endocrine therapy - Not specified Radiotherapy - No prior or concurrent radiotherapy for metastatic disease Surgery - No prior or concurrent radiofrequency ablation for metastatic disease - No prior or concurrent cryotherapy/other ablative techniques for metastatic disease Other - No other concurrent investigational therapy - No concurrent oral anticoagulation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Jean-NicolasVauthey, Study Chair, M.D. Anderson Cancer Center
Additional Information:
Study ID Numbers: CDR0000331853; NCI-6021,MDA-ID-02636
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070265
Other Stage 4 Colon Cancer Studies:
1. Gene Therapy in Patients With Colon Cancer That Has Spread to the Liver
2. Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors
3. Radiofrequency Ablation Followed By Hepatic Artery Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
4. Floxuridine, Dexamethasone, and Irinotecan After Surgery in Treating Patients With Liver Metastases From Colorectal Cancer
5. Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer
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Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
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