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- Klinische proef NCT00066846
Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy
A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab (Avastin®) Plus 5-Fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancers That Have Progressed After Standard Chemotherapy
RATIONALE: Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as fluorouracil and leucovorin use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with fluorouracil and leucovorin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
- Determine the response rate of patients treated with bevacizumab, fluorouracil, and leucovorin calcium for stage IV colorectal cancer that has progressed after standard chemotherapy.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the safety of administering "bolus" and continuous infusion fluorouracil and leucovorin calcium in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study. Patients receive 1 of 2 treatment regimens.
- Regimen I: Patients receive bevacizumab IV on days 1, 15, 29, and 42 (every 2 weeks) and leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV bolus on days 1, 8, 15, 22, 29, and 36.
- Regimen II: Patients receive bevacizumab as in regimen I and CF IV over 2 hours and 5-FU IV bolus followed by a continuous infusion over 22 hours on days 1, 2, 15, 16, 29, 30, 43, and 44.
For both regimens, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for tumor response and survival.
PROJECTED ACCRUAL: Various NCI-designated Clinical Cancer Centers and other medical institutions across the United States will participate in this study. A total of 35-125 patients will be accrued for this study within 3 months.
Studietype
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Alaska
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Anchorage, Alaska, Verenigde Staten, 99519-6604
- Providence Alaska Medical Center
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California
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Los Angeles, California, Verenigde Staten, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Verenigde Staten, 90024
- Jonsson Comprehensive Cancer Center, UCLA
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Colorado
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Aurora, Colorado, Verenigde Staten, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06520-8028
- Yale Comprehensive Cancer Center
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20007
- Lombardi Cancer Center
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30342-1701
- CCOP - Atlanta Regional
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Maywood, Illinois, Verenigde Staten, 60153
- Loyola University Medical Center
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Iowa
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Iowa City, Iowa, Verenigde Staten, 52242-1009
- Holden Comprehensive Cancer Center
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Sioux City, Iowa, Verenigde Staten, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Verenigde Staten, 67214-3882
- CCOP - Wichita
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Maine
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Bangor, Maine, Verenigde Staten, 04401
- Cancer Care of Maine
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48106
- Saint Joseph Mercy Health System
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Minnesota
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Duluth, Minnesota, Verenigde Staten, 55805
- St. Mary's/Duluth Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39216-4505
- University of Mississippi Medical Center
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Montana
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Billings, Montana, Verenigde Staten, 59101
- CCOP - Montana Cancer Consortium
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89106
- Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Verenigde Staten, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Verenigde Staten, 10021
- New York Weill Cornell Cancer Center at Cornell University
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Verenigde Staten, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, Verenigde Staten, 58122
- Meritcare Roger Maris Cancer Center
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106-5065
- Ireland Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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South Dakota
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Sioux Falls, South Dakota, Verenigde Staten, 57104
- Sioux Valley Clinics - Oncology
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Vermont
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Burlington, Vermont, Verenigde Staten, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Richmond, Virginia, Verenigde Staten, 23298-0037
- Massey Cancer Center
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Washington
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Seattle, Washington, Verenigde Staten, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Verenigde Staten, 98101
- CCOP - Virginia Mason Research Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed colorectal adenocarcinoma
- Stage IV (metastatic) disease
- Not curable by surgery or radiotherapy
Must have received prior standard chemotherapy regimens, including oxaliplatin and irinotecan, and meet both of the following criteria:
- Disease progression during or after irinotecan-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant irinotecan-based therapy
- Disease progression during or after oxaliplatin-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant oxaliplatin-based therapy
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL (transfusion allowed)
- No evidence of bleeding diathesis or coagulopathy
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST less than 5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 5 times ULN
- PT and INR no greater than 1.5 times ULN
- PTT no greater than ULN
Renal
- Creatinine no greater than 1.5 times ULN
- Proteinuria less than grade 1 OR
- Proteinuria less than 500 mg/24 hours
Cardiovascular
- No prior stroke
- No uncontrolled high blood pressure
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart disease
- No thromboembolism within the past 6 months
Other
- Chemonaive
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- No significant traumatic injury within the past 6 weeks
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to bevacizumab or other study agents
- No active infection
- No psychiatric illness or social situation that would preclude study compliance
- No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture
No CNS disease, including either of the following:
- Primary brain tumor
- Seizures not controlled with standard medical therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 8 weeks since prior monoclonal antibody therapy
- No prior bevacizumab
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)
Surgery
- More than 6 weeks since prior major surgical procedure or open biopsy
- More than 7 days since prior fine needle aspiration or core biopsy
- No concurrent surgery
Other
- Recovered from prior therapy
- At least 3 weeks since prior cytotoxic agents
No concurrent therapeutic anticoagulation
- Prophylactic anticoagulation of venous access devices allowed provided PT/INR or PTT criteria are met
- No concurrent chronic aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational or commercial agents for the malignancy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Masker: Geen (open label)
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Helen X. Chen, MD, NCI - Investigational Drug Branch
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Colon Ziekten
- Darmziekten
- Intestinale neoplasmata
- Rectale ziekten
- Colorectale neoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Beschermende middelen
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Micronutriënten
- Vitaminen
- Calciumregulerende hormonen en middelen
- Tegengif
- Vitamine B-complex
- Fluoruracil
- Bevacizumab
- Leucovorin
- Calcium
- Levoleucovorine
Andere studie-ID-nummers
- CDR0000320506
- CTEP-TRC-0301
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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The Netherlands Cancer InstituteVoltooid
-
Encube Ethicals Pvt. Ltd.CBCC Global ResearchVoltooid
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Hong Kong Nasopharyngeal Cancer Study Group LimitedThe Hong Kong Anti-Cancer Society; hong Kong Cancer FundVoltooid
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Boston UniversityWervingOppervlakkig basaalcelcarcinoom | Plaveiselcelcarcinoom in situVerenigde Staten
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The Cleveland ClinicNational Cancer Institute (NCI)BeëindigdActinische keratose | Orgaan- of weefseltransplantatie; complicatiesVerenigde Staten
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Singapore National Eye CentreSingapore Eye Research Institute; Nanchang UniversityVoltooidGlaucoom | Wond genezen | TrabeculectomieSingapore