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Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer



Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer

For Condition: liver metastases,Rectal Cancer,Colon Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Chemoprotective drugs such as dexamethasone may protect normal cells from the side effects of chemotherapy. Combining more than one chemotherapy drug and giving them after surgery may kill any remaining tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining adjuvant hepatic arterial infusion with combination chemotherapy in treating patients who have resectablehepatic (liver) metastases from colorectal cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of intravenous oxaliplatin and fluorouracil when administered with leucovorin calcium in combination with hepatic arterial infusion of floxuridine and dexamethasone in patients with resectable hepatic metastases secondary to colorectal adenocarcinoma. - Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and excision repair cross-complementing genes in normal and tumor liver tissue with survival and recurrence in patients treated with this regimen. OUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil. Patients undergo surgery for resection of the liver and placement of the hepatic artery pump. - Hepatic arterial infusion (HAI) therapy: Approximately 4 weeks after surgery, patients receive HAI therapy comprising floxuridine and dexamethasone on day 1. - Patients receive oxaliplatin IV and leucovorin calcium IV over 120 minutes and fluorouracil IV bolus (followed by a 48-hour infusion of fluorouracil) on days 15 and 29. Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Treatment repeats every 36 days for up to 6 courses in the absence of disease recurrence or unacceptable toxicity. Patients are followed every 3 months after the completion of treatment. PROJECTED ACCRUAL: A total of 2-48 patients will be accrued for this study within 12-16 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal adenocarcinoma metastatic to the liver - No clinical or radiographic evidence of extrahepatic disease - Potentially completely resectable hepatic metastases without current evidence of other metastatic disease - No ascites PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% 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 Hepatic - Bilirubin no greater than 1.5 mg/dL - No hepatic encephalopathy Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 3 weeks since prior chemotherapy - No prior oxaliplatin - No prior cisplatin - No prior hepatic arterial infusion of floxuridine Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy to the pelvis - No prior radiotherapy to the liver Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
NancyKemeny,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Nancy  Kemeny 212-639-8068


Additional Information:
Study ID Numbers:  CDR0000298988;  MSKCC-03005
Study Start Date: 
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059930

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