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Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer Clinical research trials and Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer. Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer  Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
For Condition: adenocarcinoma of the rectum,liver metastases,stage 4 colon cancer,Stage 4 rectal cancer,adenocarcinoma of the colon
Status: Recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan 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. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery. PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic (liver) metastases from colorectal cancer.
Details: OBJECTIVES: - Determine the toxicity of hepatic arterial infusion with floxuridine and systemic irinotecan adjuvant to liver metastases resection or ablation with or without resection in patients with hepatic metastases secondary to colorectal cancer. - Determine the overall survival of patients treated with this regimen. - Determine the time to any hepatic recurrence or progression in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (liver metastases resection only vs ablation with or without resection). Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 28-94 patients (14-47 patients per stratum) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic colorectal adenocarcinoma - Primary colorectal adenocarcinoma that has been completely resected (R0 disease) - No evidence of residual, viable tumor by abdominal/pelvic helical CT scan or MRI with IV contrast - Metastatic disease - No more than 9 liver metastases - All lesions completely resected or completely treated by ablation (with or without resection) - All lesions treated by ablation must have been less than 5 cm in size and at least 5 mm away from main/left/right portal vein, common bile duct, and inferior vena cava - All resected lesions must have a negative surgical margin (R0) - Disease progression after prior systemic irinotecan for metastatic disease allowed - No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection - No other prior resection of extrahepatic metastases - Must have the entire liver remnant perfused with a single catheter - Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Absolute granulocyte count at least 1,500/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2 mg/dL - Alkaline phosphatase no greater than 2.0 times upper limit of normal (ULN) - AST and ALT no greater than 2.0 times ULN - No active hepatitis B or C infection - No histological evidence of cirrhosis Renal - Creatinine no greater than 1.5 times ULN - Calcium less than 1.3 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Postmenopausal women must be amenorrheic for at least 12 consecutive months to be deemed not fertile - Medically fit to begin chemotherapy between 4 and 8 weeks after surgery - Prior cancer allowed if all of the following criteria are met: - Undergone potentially curative therapy for all prior malignancies - No other malignancy within the past 5 years except the following: - Effectively treated basal cell or squamous cell skin cancer - Carcinoma in situ of the cervix that has been effectively treated by surgery alone - Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone - No evidence of recurrence of any prior malignancy - No prior hepatic arterial infusion pump malfunction, malperfusion, or infection PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunologic or biologic therapy Chemotherapy - No prior chemotherapy within 4 weeks before hepatic resection or hepatic ablation (with or without resection) - No prior hepatic arterial infusion with fluorouracil or floxuridine Endocrine therapy - Not specified Radiotherapy - No concurrent adjuvant radiotherapy to the pelvis - No other concurrent radiotherapy Surgery - See Disease Characteristics Other - No other concurrent systemic therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
YumanFong, Study Chair, Memorial Sloan-Kettering Cancer Center
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Kenneth Tanabe 617-724-3868
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: CDR0000305857; ACOSOG-Z05032
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063960
Other Stage 4 Rectal Cancer Studies:
1. Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
2. Gene Therapy in Patients With Colon Cancer That Has Spread to the Liver
3. Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors
4. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer
5. Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
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Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
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