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Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver Clinical research trials and Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver. Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver clinical trial. Test subjects typically receive the most effective healthcare possible for their Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 > "S" Clinical Trials Conditions > Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver  Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
For Condition: Rectal Cancer,liver metastases,Colon Cancer
Status: No longer recruiting
Sponsor(s): University of Washington , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any remaining tumor cells. PURPOSE: Phase II trial to determine the effectiveness of surgery with or without radiofrequency ablation followed by irinotecan in treating patients who have colorectal cancer that is metastatic to the liver.
Details: OBJECTIVES: - Determine the disease-free survival in patients with hepatic metastases from primary colorectal carcinoma treated with surgical resection with or without radiofrequency ablation followed by irinotecan. - Determine the overall survival in patients treated with this regimen. - Determine the treatment-related toxicity of this regimen in these patients. - Correlate the measurement of molecular markers with clinical outcome in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to treatment with radiofrequency ablation in addition to resection (yes vs no). Patients undergo surgical resection with or without radiofrequency ablation. Beginning 4-8 weeks after surgery, patients receive irinotecan IV over 90 minutes on day 1. Chemotherapy repeats every 3 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary colorectal adenocarcinoma - Hepatic metastases that are considered completely resectable - No more than 4 metastases by dual phase CT scan OR - Hepatic metastases that are not completely resectable but are amenable to complete destruction with resection and radiofrequency ablation - More than 4 metastases allowed if all disease can be resected or destroyed in situ with radiofrequency ablation - No extrahepatic disease in any location - No recurrent or second primary colorectal cancer by colonoscopy within the past year - Received prior adjuvant chemotherapy with a fluorouracil-based regimen with the last dose at least 1 month prior to surgery - No prior radiofrequency ablation with residual viable intrahepatic disease by CT scan - No plans to be treated with radiofrequency ablation alone without surgical resection PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 5 times ULN - No Gilbert's disease or other known defect in hepatic conjugation or glucuronidation Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No myocardial infarction within the past 6 months - No congestive heart failure requiring therapy Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 30 days after study - No other malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix - No active serious infection - No other serious underlying medical condition or severe concurrent disease that would preclude study participation - No dementia, significantly altered mental status, or psychiatric illness that would preclude study participation - No known hypersensitivity to irinotecan - No known infection with HIV or AIDS - No uncontrolled diabetes mellitus - No history of seizures - No drug or alcohol abuse within the past year PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No prior irinotecan Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to more than 30% of bone marrow - No prior radiotherapy to the liver - At least 3 months since prior radiotherapy to the pelvis or other areas Surgery: - See Disease Characteristics - No prior resection of hepatic metastases (wedge biopsy allowed) Other: - No concurrent phenytoin, phenobarbital, or other antiepileptic medication - No concurrent enrollment in other investigational drug trials
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KevinBillingsley, Study Chair, University of Washington
University of Washington School of Medicine
Seattle, Washington, 98195
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Additional Information:
Study ID Numbers: CDR0000069177; UWASH-440E-ONC-0020-250,UWASH-1200,NCI-G01-2045,CWRU-UWMC-1200,CWRU-040106
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030563
Other Colon Cancer Studies:
1. Computed Tomographic Colonography in Detecting Colorectal Polyps or Cancer
2. Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps
3. Sulindac and Plant Compounds in Preventing Colon Cancer
4. Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
5. Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
Related Studies:
Other Colon Cancer Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
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