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Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer. Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer  Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
For Condition: Rectal Cancer,Colon Cancer,liver metastases
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. Cryosurgery kills cancer cells by freezing them. Combining more than one chemotherapy drug with cryosurgery and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of intrahepatic and intravenouscombination chemotherapy with or without cryosurgery in treating unresectableliver metastases from colorectal cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of oxaliplatin and fluorouracil when given with leucovorin calcium and hepatic intra-arterial floxuridine and dexamethasone with or without cryosurgery (group I cryosurgery closed to accrual as of 10/13/03) in patients with unresectable liver metastases from colorectal cancer. - Determine, preliminarily, the anti-tumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil. Patients are assigned to one of two treatment groups. (Group I closed to accrual as of 10/13/03.) - Group I (closed to accrual as of 10/13/03): Patients with no more than 8 hepatic metastases and no metastases greater than 5 cm in diameter undergo cryosurgery prior to chemotherapy. Chemotherapy is delayed for at least 4 weeks after cryosurgery. - Group II: Patients with more than 8 hepatic metastases or at least one metastases greater than 5 cm in diameter do not undergo cryosurgery prior to chemotherapy. Beginning 2 weeks after pump placement surgery, all patients receive floxuridine and dexamethasone by hepatic intra-arterial infusion continuously on days 1-14; oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on days 15 and 29; and fluorouracil IV continuously over 48 hours on days 15-16 and 29-30. Courses repeat every 36 days in the absence of disease progression or unacceptable toxicity. 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. PROJECTED ACCRUAL: Approximately 4-72 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the colon or rectum with unresectable liver metastases that comprise less than 70% of liver parenchyma - No extrahepatic disease - No ascites PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - No hepatic encephalopathy Renal: - Creatinine no greater than 1.5 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - No obstruction of gastrointestinal tract or genitourinary tract - No symptomatic peripheral sensory neuropathy - No active infection - No other malignancy except resectable primary colorectal carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior floxuridine - If undergoing cryosurgery (group I cryosurgery closed to accrual as of 10/13/03), must have received one of the following: - Systemic chemotherapy for metastatic disease - Adjuvant therapy within the past 6 months comprising fluorouracil with or without levamisole for resected primary colorectal carcinoma - Adjuvant therapy within the past 12 months comprising fluorouracil and leucovorin calcium with or without levamisole for resected primary colorectal carcinoma Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to 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: CDR0000068395; MSKCC-00009,NCI-G00-1896
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008294
Other Colon Cancer Studies:
1. Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma
2. Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
3. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
4. Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
5. Computed Tomographic Colonography in Detecting Colorectal Polyps or Cancer
Related Studies:
Other Colon Cancer Clinical Trials
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Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
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