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Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver Clinical research trials and Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver. Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
For Condition: Stage 4 rectal cancer,liver metastases,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.
Details: OBJECTIVES: I. Determine the efficacy and tolerance of oxaliplatin by hepatic perfusion combined with intravenous leucovorin calcium and fluorouracil in patients with liver metastases from colorectal cancer. PROTOCOL OUTLINE: Patients receive oxaliplatin by hepatic perfusion over 2 hours on day 1 plus leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. If a good response is achieved after 8 courses of chemotherapy, patients may undergo surgical resection of metastases. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven colorectal cancer metastatic to the liver - Unresectable disease - Less than 50% invasion of the liver - Measurable disease; No prior irradiation; Largest diameter at least 20 mm - No detectable extrahepatic disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior intravenous oxaliplatin; No more than 1 prior regimen of intravenous chemotherapy for metastatic disease; Primary chemotherapy of fluorouracil allowed if stable or progressive disease; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: Under 75 - Performance status: WHO 0-2 - Life expectancy: Greater than 2 months - Hematopoietic: WBC at least 4,000/mm3; Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 35 micromoles/L - Renal: Creatinine less than 130 micromoles/L - Cardiovascular: No severe cardiac insufficiency - Pulmonary: No respiratory disease that would preclude study - Other: No other serious illness that would preclude study; No psychological illness that would preclude study; No peripheral neuropathy; No prior malignancy not considered cured; Not pregnant; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichelDucreux, Study Chair, Federation Nationale des Centres de Lutte Contre le Cancer
Institut J. Paoli and I. Calmettes
Marseille, , 13273
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , 34298
France
Additional Information:
Study ID Numbers: CDR0000068072; EU-20017,FRE-FNCLCC-98012-PAC-ACCORD-04
Study Start Date: January 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006050
Other Liver Metastases Studies:
1. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
2. Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer
3. Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
4. SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
5. Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
Related Studies:
Other liver metastases Clinical Trials
Other Clinical Trials
Other Montpellier Clinical Trials
Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
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