Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
NCT ID: NCT00062426
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2003-05-31
2011-02-28
Brief Summary
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PURPOSE: This randomized phase III trial is to see if oxaliplatin and bevacizumab work better when combined with either fluorouracil and leucovorin or capecitabine in treating patients who have metastatic or recurrent colorectal cancer.
Detailed Description
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* Compare the incidence of grade 3 and 4 toxic effects occurring within the first 12 weeks of treatment with 2 different schedules of oxaliplatin, bevacizumab (Avastin™), leucovorin calcium, and fluorouracil or with oxaliplatin, Avastin™, and capecitabine in patients with advanced colorectal cancer.
* Compare the overall response rate, progression-free survival, and time to treatment failure in patients treated with these regimens.
* Compare the composite toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive bevacizumab (Avastin™) IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil (5-FU) IV over 46 hours beginning on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium IV over 10 minutes and 5-FU IV over 3 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 3 months for at least 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 375 patients (125 per treatment arm) will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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bevacizumab
capecitabine
fluorouracil
leucovorin calcium
oxaliplatin
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the colon or rectum
* Metastatic or recurrent disease not amenable to potentially curative treatment
* At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* Histological or cytological confirmation is required for a solitary target lesion
* No CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGPT and SGOT no greater than 3 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 30 mL/min
Cardiovascular
* No myocardial infarction within the past 6 months
* No clinical evidence of congestive heart failure
* No unstable coronary artery disease
Pulmonary
* No interstitial pneumonia
* No extensive symptomatic fibrosis of the lungs
Gastrointestinal
* Able to tolerate oral medication
* No lack of physical integrity of the upper gastrointestinal tract
* No malabsorption syndrome
* No swallowing difficulties
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No other concurrent serious illness
* No uncontrolled infection
* No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix or any other cancer for which the patient has been off all therapy and in remission for at least 5 years
* No peripheral neuropathy
* No hypersensitivity to any of the study drugs or their ingredients
* No known dihydropyrimidine dehydrogenase deficiency
* No other medical or psychiatric disorder that would preclude giving informed consent or complying with study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent prophylactic hematopoietic growth factor therapy
* No prior bevacizumab (Avastin™)
Chemotherapy
* At least 6 months since prior adjuvant fluorouracil, leucovorin calcium, and irinotecan
* No prior oxaliplatin
* No prior chemotherapy for metastatic or recurrent disease
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No concurrent radiotherapy unless for the control of bone pain
Surgery
* Recovered from prior surgery
* No prior organ allografts
Other
* More than 4 weeks since prior investigational drugs
* No concurrent iced mouth rinses for the prevention of stomatitis
* No concurrent cold cap alopecia prevention
* No concurrent pyridoxine
* No concurrent sorivudine or chemically-related analogues (e.g., brivudine)
* No concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, or warfarin
18 Years
ALL
No
Sponsors
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Prologue Research International
INDUSTRY
Principal Investigators
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Richard A. Gams, MD
Role: STUDY_CHAIR
Prologue Research International
Lauri Welles, MD
Role:
Sanofi-Synthelabo
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Valley Tumor Medical Group
Lancaster, California, United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, United States
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Lynn Regional Cancer Center West
Boca Raton, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Oncology Associates
Jacksonville, Florida, United States
Hematology and Oncology Consultants, P.A.
Orlando, Florida, United States
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Peachtree Hematology and Oncology Consultants, P.C.
Atlanta, Georgia, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Saint Anthony Medical Center
Rockford, Illinois, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States
Cooper Cancer Institute at Cooper University Hospital
Voorhees Township, New Jersey, United States
Advanced Oncology Associates
Armonk, New York, United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, United States
Arena Oncology Associates
Great Neck, New York, United States
St. Vincents Comprehensive Cancer Center
New York, New York, United States
New York University Medical Center
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Physicians East - Quadrangle
Greenville, North Carolina, United States
Raleigh Hematology/Oncology Associates, P.A. - Wake Practice
Raleigh, North Carolina, United States
Hematology Oncology Consultants Inc
Columbus, Ohio, United States
Hematology/Oncology of Salem
Salem, Oregon, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, United States
McCleod Cancer and Blood Center
Johnson City, Tennessee, United States
Memphis Cancer Center
Memphis, Tennessee, United States
West Clinic
Memphis, Tennessee, United States
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States
Lone Star Oncology
Austin, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
South Texas Oncology and Hematology
San Antonio, Texas, United States
Center for Cancer Prevention and Care at Scott and White Clinic
Temple, Texas, United States
Medical Consultants
Milwaukee, Wisconsin, United States
Countries
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References
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Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.
Other Identifiers
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PROLOGUE-SANOFI-ARD5099
Identifier Type: -
Identifier Source: secondary_id
SANOFI-ARD5099
Identifier Type: -
Identifier Source: secondary_id
CDR0000304771
Identifier Type: -
Identifier Source: org_study_id