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Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Clinical research trials and Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer. Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer  Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
For Condition: stage 4 colon cancer,Stage 4 rectal cancer
Status: No longer recruiting
Sponsor(s): Genentech ,
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether monoclonal antibody therapy is more effective with or without irinotecan in treating metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan plus monoclonal antibody therapy in treating patients who have metastatic colorectal cancer.
Details: OBJECTIVES: I. Evaluate the efficacy, in terms of duration of survival, time to disease progression, objective response rate, and duration of objective response of bevacizumab (rhuMAb VEGF) with fluorouracil, leucovorin calcium, and irinotecan as opposed to placebo with fluorouracil, leucovorin calcium, and irinotecan in patients with metastatic colorectal cancer. II. Evaluate the safety of these regimens in these patients. III. Determine the plasma pharmacokinetics of irinotecan with fluorouracil, leucovorin calcium, and bevacizumab (rhuMAb VEGF) versus irinotecan with fluorouracil and leucovorin calcium in these patients. IV. Determine the pharmacokinetics of bevacizumab (rhuMAb VEGF) in these patients. V. Evaluate and compare the quality of life in patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, active-controlled, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), site of primary disease (colon vs rectum), and number of metastatic sites (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 1-2 minutes and fluorouracil IV over 1-2 minutes weekly for 4 weeks. Patients also receive placebo IV over 30-90 minutes every other week. Courses repeat every 6 weeks. Arm II: Patients receive irinotecan, leucovorin calcium, and fluorouracil as in arm I. Patients also receive bevacizumab (rhuMAb VEGF) IV over 30-90 minutes every other week. Courses repeat every 6 weeks. Treatment continues for a maximum of 16 courses in the absence of disease progression or unacceptable toxicity. All patients with progressive disease may continue to receive treatment on this study with another chemotherapy agent with or without bevacizumab (rhuMAb VEGF). Patients in arm I with progressive disease may continue to receive another chemotherapy agent and are not allowed to receive bevacizumab (rhuMAb VEGF). Patients in arm II with progressive disease may continue to receive bevacizumab (rhuMAb VEGF) alone or in combination with another chemotherapy agent. Patients are followed every 4 months for survival. PROJECTED ACCRUAL: Approximately 900 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic colorectal cancer - At least 2 bidimensionally measurable lesions - No CNS disease (e.g., primary brain tumor, seizures not controlled with standard therapy, or any brain metastases) - No clinically detectable ascites --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy for colorectal cancer - Chemotherapy: At least 12 months since prior fluoropyrimidines with leucovorin and/or levamisole; No other prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 14 days since prior radiotherapy; No prior radiotherapy to any indicator lesion - Surgery: At least 28 days since prior surgical procedure; At least 7 days since prior fine needle aspiration; No concurrent major surgical procedure - Other: At least 10 days since prior full-dose oral or parenteral anticoagulants except to maintain patency of pre-existing, permanent indwelling IV catheters; At least 10 days since prior full-dose oral or parenteral thrombolytic agent; At least 28 days since participation in other experimental drug study; No chronic, daily aspirin or nonsteroidal anti-inflammatory medications; No concurrent full-dose oral or parenteral anticoagulants (except for indwelling IV catheter maintenance) or thrombolytic agent --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: More than 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 75,000/mm3; Hemoglobin at least 9 g/dL (may be transfused); No bleeding diathesis or coagulopathy - Hepatic: AST or ALT no greater than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver metastasis present); Bilirubin no greater than 1.6 mg/dL; International normalized ratio less than 1.5 - Renal: Creatinine no greater than 2.0 mg/dL; No proteinuria or clinically significant impairment of renal function - Cardiovascular: No clinically significant cardiovascular disease including uncontrolled hypertension, myocardial infarction, or unstable angina within past year; No New York Heart Association class II-IV congestive heart failure within past year; No serious cardiac arrhythmia requiring medication or grade II or greater peripheral vascular disease within past year - Other: Must be able to tolerate CT scan contrast dye; No other invasive malignancy within past 5 years except basal cell skin cancer; No CNS disease including uncontrolled seizures or stroke; No active infection requiring parenteral antibiotics; No serious nonhealing wound, ulcer, or bone fracture; No other disease or medical condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BethDrena, Study Chair, Genentech
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Oncology Radiation Associates
Miami, Florida, 33133
United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, 28603
United States
Texas Oncology, P.A.
Dallas, Texas, 75231
United States
University of Tennessee, Memphis
Memphis, Tennessee, 38163
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Asheville Hematology and Oncology Associates, P.A.
Asheville, North Carolina, 28801
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
Overlook Hospital
Summit, New Jersey, 07902-0220
United States
nTouch Research Corporation
Raleigh, North Carolina, 27610
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Cancer Research Network Inc.
Plantation, Florida, 33324
United States
St. Luke's-Roosevelt Hospital
New York City, New York, 10019
United States
Boulder Valley Oncology, LLP
Boulder, Colorado, 80304
United States
US Oncology (Texas Oncology) PA
Houston, Texas, 77030
United States
Minnesota Oncology-Hematology, P.A.
Minneapolis, Minnesota, 55407
United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Missouri Cancer Care, P.C.
St. Charles, Missouri, 63301
United States
US Oncology, Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, 32803
United States
Veterans Affairs Medical Center - Reno
Reno, Nevada, 89520
United States
Helen and Harry Gray Cancer Center
Hartford, Connecticut, 06106
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
US Oncology, Texas Cancer Center
Denton, Texas, 76205
United States
American Medical Research Institute, Inc.
Cumming, Georgia, 30040
United States
Milstein Hospital Building
New York City, New York, 10032
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
United States
Haematology-Oncology Associates, Inc.
Toledo, Ohio, 43623-4474
United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
United States
Saint Clare's Hospital
Denville, New Jersey, 07834
United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
United States
Northwest Cancer Specialists
Vancouver, Washington, 98664
United States
Oncology/Hematology Associates
Indianapolis, Indiana, 46227
United States
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, 92708
United States
Raleigh Hematology Oncology Associates, P.C.
Raleigh, North Carolina, 27607
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Northern Virginia Oncology Group, P.C.
Fairfax, Virginia, 22031
United States
Cancer Research of Long Island, Inc.
Great Neck, New York, 11022
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, 72703
United States
US Oncology, Birmingham Hematology and Oncology Associates
Alabaster, Alabama, 35007
United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
United States
Carraway Cancer Center
Birmingham, Alabama, 35234
United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
United States
Kaiser Permanente - Portland
Portland, Oregon, 97227
United States
Oklahoma Oncology Inc.
Tulsa, Oklahoma, 74104
United States
Pacific Hematology/Oncology
San Francisco, California, 94115
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902
United States
Cedars Medical Center
Miami, Florida, 33136
United States
University Medical Center - Las Vegas
Las Vegas, Nevada, 89102-2386
United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, 54548
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
Midwest Clinical Research Group, Inc.
Highland Park, Illinois, 60035
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43222
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Texas Oncology, P.A.
Austin, Texas, 78745
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
US Oncology, Rocky Mountain Cancer Center
Albany, New York, 12203
United States
Regional Hematology Oncology Associates
Durham, North Carolina, 27704
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Oncology Hematology Consultants, PA
Sarasota, Florida, 34239
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
St. Elizabeth's Medical Center of Boston
Brighton, Massachusetts, 02135
United States
Center for Hematology-Oncology
Boca Raton, Florida, 33486
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Piedmont Hospital, Inc.
Atlanta, Georgia, 30309
United States
Raleigh Internal Medicine
Raleigh, North Carolina, 27609
United States
Washington University Siteman Cancer Center
St. Louis, Missouri, 63110
United States
Offices of R.H. Clark and J.A. Axelson
Jackson, Michigan, 49201
United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
United States
Associates in Oncology and Hematology
Rockville, Maryland, 20850
United States
Southfield Oncology Institute, Inc.
Southfield, Michigan, 48076
United States
Rhinelander Medical Center
Rhinelander, Wisconsin, 54501
United States
Alan B. Newman MD and Associates
San Francisco, California, 94115
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Dial Research Associates
Brentwood, Tennessee, 37027
United States
Rush North Shore Medical Center
Skokie, Illinois, 60076
United States
Norton Healthcare Pavilion
Louisville, Kentucky, 40202
United States
Oncology Hematology Associates of Kansas City
Kansas City, Missouri, 64131
United States
Oncology/Hematology Associates
Overland Park, Kansas, 66210
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
New England Hematology/Oncology Associates, P.C.
Wellesley, Massachusetts, 02181
United States
Midwest Oncology Consortium
Kansas City, Missouri, 64111
United States
nTouch Research
Oklahoma City, Oklahoma, 73109
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Southwest Cancer Care
Escondido, California, 92025-4404
United States
US Oncology - Rocky Mountain Cancer Center
Littleton, Colorado, 80120
United States
HemOnCare, P.C.
Brooklyn, New York, 11235
United States
Medical Center East
Birmingham, Alabama, 35235-3401
United States
Oncology and Hematology, P.C.
Kalamazoo, Michigan, 49007
United States
Interlakes Oncology/Hematology PC
Rochester, New York, 14623
United States
US Oncology - Florida Community Cancer Center
Bradenton, Florida, 34209
United States
Florida Oncology Associates
Orange Park, Florida, 32073
United States
Scott and White Clinic
Temple, Texas, 76508
United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, 84124
United States
University of California Los Angeles School of Medicine
Los Angeles, California, 90095
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Hematology/Oncology Associates of NE Pennsylvania, P.C.
Scranton, Pennsylvania, 18510
United States
Western Washington Oncology, Inc.
Olympia, Washington, 98502
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, 06790
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
The Oncology Clinic, P.C.
Colorado Springs, Colorado, 80907
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
United States
Rocky Mountain Cancer Center
Englewood, Colorado, 80110
United States
Hematology & Oncology Associates of Virginia
Richmond, Virginia, 23226
United States
Advanced Oncology Associates
Armonk, New York, 10504
United States
Veterans Affairs Medical Center - Columbia
Columbia, South Carolina, 20209
United States
Virginia Mason Medical Center
Seattle, Washington, 98111
United States
St. John's Mercy Medical Center
St. Louis, Missouri, 63141
United States
Palmetto Richland Memorial Hospital
Columbia, South Carolina, 29203
United States
Additional Information:
Study ID Numbers: CDR0000068496; UCLA-0008022,GENENTECH-AVF2107g
Study Start Date: July 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012233
Other Stage 4 Rectal Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Colorectal Cancer
2. Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
3. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
4. Gemcitabine in Treating Patients With Advanced Colorectal Cancer
5. Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
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