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Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer Clinical research trials and Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer. Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer  Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
For Condition: stage 4 colon cancer,recurrent rectal cancer,liver metastases,Stage 4 rectal cancer,recurrent colon cancer
Status: No longer recruiting
Sponsor(s): Beckman Research Institute , 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. Combining more than one drug and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus systemic fluorouracil and leucovorin in treating patients with liver metastases from colorectal cancer.
Details: OBJECTIVES: - Evaluate the efficacy of hepatic resection followed by portal vein infusion of floxuridine plus systemic fluorouracil/leucovorin calcium in patients with metastatic colorectal cancer. - Study the toxic effects of adjuvant chemotherapy following hepatic resection. - Evaluate mRNA expression of enzymes that may be important to the cytotoxicity of fluoropyrimidines in tumor cells, including thymidylate synthase, ribonucleotide reductase, and folylglutamyl synthetase, by polymerase chain reaction and immunohistochemistry. OUTLINE: Following resection of the liver and all extrahepatic colorectal cancer, patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks. If biopsy-proven metastatic disease develops, treatment may be stopped at the investigator's discretion. Continuation of regional therapy should be considered for extrahepatic failure. No concurrent radiotherapy is permitted. Patients are followed every 3 months for 3 years, then every 6 months for survival. PROJECTED ACCRUAL: It is expected that 50 patients will be entered over approximately 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal carcinoma or radiologically confirmed colorectal carcinoma in a synchronous metastasis - Intrahepatic metastases required - No more than 15 metastases involving no more than 60% of functioning liver - No extrahepatic disease unless: - Resectable anastomotic or locally recurrent tumor - Resectable mesenteric lymph node involvement in patients undergoing initial resection of primary colorectal carcinoma - Disease extension from liver metastasis amenable to en bloc resection (e.g., diaphragm wall, kidney, abdominal wall) - No biopsy-proven chronic active hepatitis PATIENT CHARACTERISTICS: Age: - Physiologic 18 to 70 Performance status: - Karnofsky 60%-100% Hematopoietic: - AGC at least 1,500 - Platelets at least 100,000 Hepatic: - Bilirubin no greater than 2.0 mg/dL (unless reversibly obstructed by metastasis) Renal: - Creatinine no greater than 2.0 mg/dL Other: - No second malignancy within 5 years except adequately treated: - Nonmelanomatous skin cancer - In situ bladder cancer - In situ cervical cancer - No pregnant women PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior mitomycin or nitrosoureas allowed Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the liver - At least 3 weeks since radiotherapy and recovered - Prior pelvic radiotherapy allowed - No planned concurrent radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LucilleLeong, Study Chair, Beckman Research Institute
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000065077; CHNMC-IRB-94080,NCI-V96-1031
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002842
Other Liver Metastases Studies:
1. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
2. Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
3. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
4. Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer
5. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
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Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
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