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Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated Clinical research trials and Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated. Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated clinical trial. Participants frequently get the best healthcare available for their Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated  Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
For Condition: recurrent rectal cancer,Stage 4 rectal cancer,adenocarcinoma of the colon,adenocarcinoma of the rectum,stage 3 rectal cancer,stage 3 colon cancer,recurrent colon cancer,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , 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. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells. It is not yet known if bevacizumab is more effective with or without combination chemotherapy in treating colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have advanced or metastatic colorectal cancer that has been previously treated.
Details: OBJECTIVES: - Compare the response, time to progression, and overall survival of patients with previously treated advanced or metastatic colorectal adenocarcinoma treated with oxaliplatin, leucovorin calcium, and fluorouracil with or without bevacizumab versus bevacizumab only. (Arm III closed to accrual as of 03/11/2003). - Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance status (0 vs 1 or 2), and prior radiotherapy (yes vs no). Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive leucovorin calcium IV over 2 hours and fluorouracil (5-FU) IV over 22 hours on days 1 and 2. - Arm II: Patients receive oxaliplatin, leucovorin calcium, and 5-FU as in arm I. - Arm III: Patients receive bevacizumab as in arm I. (Arm closed to accrual as of 03/11/2003). Courses in all arms repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response may receive 2 additional courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 880 patients (293 per treatment arm) will be accrued for this study within 18 months. (Arm III closed to accual as of 03/11/2003).
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 - Advanced or metastatic disease - Must have received a fluoropyrimidine-based regimen and an irinotecan-based regimen, either alone or in combination, for advanced disease - May have relapsed within 6 months of adjuvant therapy with fluorouracil (5-FU) (or combination 5-FU and irinotecan) and progressed after single-agent irinotecan - Measurable disease - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No history of thrombotic or hemorrhagic disorders Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 5 times ULN - INR no greater than 1.5 - PTT no greater than ULN Renal: - Creatinine no greater than 1.5 times ULN - Proteinuria less than 1+ (i.e., 0 or trace) OR - Protein less than 500 mg by 24-hour urine collection - Proteinuria secondary to ureteral stents allowed - No proteinuria secondary to nephropathy Cardiovascular: - Controlled hypertension (less than 150/100 mm Hg) allowed if on a stable antihypertensive regimen - No prior myocardial infarction - No uncontrolled congestive heart failure - No unstable angina within the past 3 months Other: - No serious nonhealing wound, ulcer, or bone fracture - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bevacizumab Chemotherapy: - See Disease Characteristics - Recovered from prior chemotherapy - No prior oxaliplatin Endocrine therapy: - Not specified Radiotherapy: - At least 2 weeks since prior radiotherapy and recovered Surgery: - At least 28 days since prior major surgical procedure Other: - At least 10 days since prior aspirin dose of more than 325 mg/day - No concurrent therapeutic anticoagulation except prophylactic anticoagulation of venous access device - No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or cilostazol) - No concurrent oral cryotherapy on day 1 of oxaliplatin administration
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BruceGiantonio, Study Chair, Kimmel Cancer Center (KCC)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Tuft-New England Medical Center
Boston, Massachusetts, 02111
United States
Pretoria Academic Hospitals
Pretoria, , 0001
South Africa
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Genesis Medical Center
Davenport, Iowa, 52804
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Veterans Affairs Medical Center - San Juan
San Juan, , 00927-5800
Puerto Rico
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, 32608-1197
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
MBCCOP - San Juan
San Juan, , 00927-5800
Puerto Rico
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80224
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212-2637
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Additional Information:
Study ID Numbers: CDR0000068951; CTSU,E-3200
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025337
Other Adenocarcinoma Of The Colon Studies:
1. Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
2. Combination Chemotherapy in Treating Patients With Colorectal Cancer
3. SU011248 in Treating Patients With Metastatic Colorectal Adenocarcinoma (Cancer) That Has Not Responded to Previous Treatment With Irinotecan, Oxaliplatin, and a Fluoropyrimidine With or Without Bevacizumab
4. Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
5. Gene Testing in Patients With Colon Cancer
Related Studies:
Other adenocarcinoma of the colon Clinical Trials
Other Illinois Clinical Trials
Other Decatur Clinical Trials
Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
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