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Combination Chemotherapy in Treating Patients With 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 Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With 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 Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer. Combination Chemotherapy in Treating Patients With 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 Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy in Treating Patients With 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 > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer  Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
For Condition: Colon Cancer,liver metastases,Rectal Cancer
Status: Completed
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI),Eastern Cooperative Oncology Group
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 may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of intrahepaticfloxuridine, leucovorin, and dexamethasone with that of systemicfluorouracil and leucovorin in treating patients who have unresectableliver metastases from colorectal cancer.
Details: OBJECTIVES: - Compare the efficacy, toxicity, and cost of hepatic artery infusion of floxuridine, leucovorin calcium (CF), and dexamethasone vs IV fluorouracil and IV CF after resection of primary disease in patients with hepatic metastases secondary to colorectal cancer. - Compare the quality of life of patients treated with these regimens. - Measure the level of thymidylate synthase present in liver metastases, and correlate these levels with objective response and survival in patients treated with these regimens. - Assess the p53 mutations, and correlate findings with objective response and survival in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, percentage of liver involvement on CT scan or MRI (less than 30% vs 30% to under 70%), prior chemotherapy (none vs adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV) completed at least 1 year before study vs adjuvant chemotherapy comprising 5-FU with or without LEV completed at least 6 months before study), and synchronous disease (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. - Arm II: Patients receive CF IV and fluorouracil IV on days 1-5. Patients with unresected primary disease undergo resection within 3-4 weeks before initiation of chemotherapy. Treatment for patients on both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 340 patients (170 per arm) will be accrued for this study within approximately 4.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Unresectable liver metastases secondary to colorectal cancer - Less than 70% liver involvement on CT scan or MRI - Liver biopsy required before study unless 1 of the following conditions are met: - Carcinoembryonic antigen greater than 30 - 5 or more liver metastases visible on CT scan or MRI - Greater than 50% to under 70% liver involvement on CT scan or MRI - Histologically proven primary colorectal cancer that is resected or appears resectable on CT scan and physical exam - Documentation of previously resected primaries must be based on pathologic results of the resected tumor - Histological documentation of synchronous disease must be based on 1 of the following: - Biopsy of primary colorectal tumor before study - Suspicious lesion on barium enema, colonoscopy, or sigmoidoscopy, and a liver biopsy positive for adenocarcinoma consistent with the primary colorectal tumor - Measurable disease - Clearly defined liver mass measuring at least 2 cm or at least 3 liver masses on CT scan or MRI - No evidence of extrahepatic disease on CT scan and physical exam - No portal vein occlusion or ascites PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - See Disease Characteristics - Bilirubin no greater than 2 times normal Renal: - Not specified Other: - No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer, carcinoma in situ of the cervix, or grade 1 bladder cancer - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 1 year since prior adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV) - At least 6 months since prior adjuvant chemotherapy comprising 5-FU with or without LEV - No other prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy except for nondisease-related conditions, e.g.: - Steroids for adrenal failure - Insulin for diabetes - Intermittent dexamethasone as an antiemetic Radiotherapy: - No prior radiotherapy to the liver Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NancyKemeny, Study Chair, Memorial Sloan-Kettering Cancer Center
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Westmead Hospital
Westmead, New South Wales, 2145
Australia
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
United States
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa, 50314
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
San Juan City Hospital
San Juan, , 00936-7344
Puerto Rico
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, 68128-4157
United States
Instituto de Enfermedades Neoplasicas
Lima, , 34
Peru
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Additional Information:
Study ID Numbers: CDR0000064553; CALGB-9481,ECOG-C9481
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002716
Other Liver Metastases Studies:
1. Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
2. Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
3. DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
4. Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
5. Biological Therapy in Treating Patients With Metastatic Cancer
Related Studies:
Other liver metastases Clinical Trials
Other Nebraska Clinical Trials
Other Papillion Clinical Trials
Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
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