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Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer 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 Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer Clinical research trials and Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer 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 Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer 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 Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer 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 Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer  Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
For Condition: stage 4 colon cancer,adenocarcinoma of the rectum,recurrent colon cancer,adenocarcinoma of the colon,recurrent rectal cancer,Stage 4 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. Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer.
Details: OBJECTIVES: I. Determine the progression-free survival at 7 months of patients with previously untreated advanced colorectal cancer treated with fluorouracil, leucovorin calcium, irinotecan, and bevacizumab. II. Determine the response rate and overall survival of this patient population treated with this regimen. III. Determine the toxicity of this treatment regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV once weekly for 4 weeks. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced or metastatic adenocarcinoma of the colon and rectum; Surgically unresectable disease - Measurable disease; Disease outside the prior radiotherapy port and/or progressive disease within the previously irradiated volume --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent sargramostim (GM-CSF) - Chemotherapy: At least 12 months since prior fluorouracil-based adjuvant chemotherapy; No prior adjuvant irinotecan - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 2 weeks since prior radiotherapy and recovered - Surgery: See Disease Characteristics - Other: No prior therapy for advanced disease; No concurrent therapeutic anticoagulation except for low-dose coumadin for maintenance of indwelling catheters --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; No hemorrhagic events within the past 6 months - Hepatic: Bilirubin normal; SGOT normal; INR no greater than 1.5 - Renal: Creatinine no greater than 1.5 times upper limit of normal - Cardiovascular: No thromboembolic events within the past 6 months - Pulmonary: No evidence of pneumonia - Other: No known hypersensitivity to recombinant humanized murine monoclonal antibodies; No evidence of significant active infection (e.g., peritonitis or wound abscess); Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BruceGiantonio, Study Chair, Eastern Cooperative Oncology Group
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Veterans Affairs Medical Center - Cleveland
Cleveland, Ohio, 44106
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Veterans Affairs Medical Center - New York
New York City, New York, 10010
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
MBCCOP-Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, 32608-1197
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, 19104-9104
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, 10466
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Pretoria Academic Hospitals
Pretoria, , 0001
South Africa
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
United States
Veterans Affairs Medical Center - Miami
Miami, Florida, 33125
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
MBCCOP - San Juan
San Juan, , 00927-5800
Puerto Rico
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
Veterans Affairs Medical Center - San Juan
San Juan, , 00927-5800
Puerto Rico
CCOP - Sooner State
Tulsa, Oklahoma, 74136
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, 68105
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
Additional Information:
Study ID Numbers: CDR0000068328; E-2200
Study Start Date: November 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006786
Other Recurrent Colon Cancer Studies:
1. Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer
2. Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer
3. Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
4. Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
5. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Related Studies:
Other recurrent colon cancer Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
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