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Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer Clinical research trials and Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer  Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
For Condition: Stage 4 rectal cancer,recurrent rectal cancer,adenocarcinoma of the colon,adenocarcinoma of the rectum,stage 3 colon cancer,stage 4 colon cancer,recurrent colon cancer,stage 3 rectal cancer
Status: No longer recruiting
Sponsor(s): 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 tumor cells. PURPOSE: Phase II trial to study the effectiveness of fluorouracil - uracil and leucovorin in treating elderly patients who have metastatic colorectal cancer.
Details: OBJECTIVES: I. Determine the response rate of elderly patients with metastatic colorectal cancer when treated with fluorouracil-uracil and leucovorin calcium. II. Evaluate the toxicity profile of this regimen in this patient population. III. Compare response rates obtained in this study with those observed in recent phase III studies in younger patients. PROTOCOL OUTLINE: Patients receive oral fluorouracil-uracil and oral leucovorin calcium every 8 hours for 28 days. Treatment continues every 35 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 75 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic colorectal adenocarcinoma - Measurable disease - No prior therapy for metastatic disease except radiotherapy to treat locally symptomatic disease --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; At least 6 months since prior adjuvant immunotherapy for colorectal cancer; No concurrent immunotherapy - Chemotherapy: See Disease Characteristics; At least 6 months since prior adjuvant chemotherapy for colorectal cancer; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy - Radiotherapy: See Disease Characteristics; At least 6 months since prior adjuvant radiotherapy for colorectal cancer - Surgery: Prior surgery allowed - Other: No other concurrent investigational drugs; No concurrent halogenated antiviral agents (e.g., lodenosine, fialuridine, FMAU, emtricitabine, and sorivudine) --Patient Characteristics-- - Age: 75 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST or ALT no greater than 2.5 times upper limit of normal (ULN) - Renal: Creatinine no greater than 1.5 times ULN - Other: No serious infection; No other serious underlying medical condition that would preclude protocol therapy; No known hypersensitivity to fluorouracil-uracil or leucovorin calcium
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHochster, Study Chair, Eastern Cooperative Oncology Group
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
MBCCOP - San Juan
San Juan, , 00927-5800
Puerto Rico
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
CCOP - Sooner State
Tulsa, Oklahoma, 74136
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
United States
Veterans Affairs Medical Center - San Juan
San Juan, , 00927-5800
Puerto Rico
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Veterans Affairs Medical Center - Cleveland
Cleveland, Ohio, 44106
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, 32608-1197
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Additional Information:
Study ID Numbers: CDR0000067511; E-1299
Study Start Date: June 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004860
Other Stage 4 Colon Cancer Studies:
1. BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
2. Radiofrequency Ablation Followed By Hepatic Artery Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
3. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
4. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
5. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
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