- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00100841
Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. To determine the safety, feasibility of administration, response rates and progression free survival among chemotherapy naïve patients with advanced colorectal cancer treated with FOLFOX6 plus bevacizumab and cetuximab (FBC).
II. To determine the survival of patients with advanced colorectal cancer treated with FBC.
III. To determine the safety of the current regimen in selected patients who have had prior MoAb therapy.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 40-67 patients will be accrued for this study.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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New York
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Bronx, New York, Verenigde Staten, 10467-2490
- Montefiore Medical 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
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum which is beyond the scope of surgical resection (MEDRA code:"Colorectal neoplasms malignant","Colorectal cancer stage IV","10010035")
- Measurable disease,
- Life expectancy of greater than 3 months
- ECOG performance status =< 1
- Leukocytes >= 3,500/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 150,000/uL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits
- Patients may not have received prior therapy with bevacizumab or cetuximab
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to radiotherapy administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating women
- Serious or non-healing wound, ulcer or bone fracture
Invasive procedures defined as follows:
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 therapy
- Anticipation of need for major surgical procedures during the course of the study
- Core biopsy within 7 days prior to D1 therapy
If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
- The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of LMW heparin
- The subject must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)
- Active infection requiring parental antibiotics on D1
- Proteinuria at baseline; subjects unexpectedly discovered to have >= 1+ proteinuria will undergo a 24-hour urine collection, which will be < 1000 mg protein/ 24 hours to be allowed participation in the study
- No currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix; patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years
Patients with clinically significant cardiovascular disease:
- Uncontrolled hypertension
- Myocardial infarction or unstable angina < 6 months prior to registration
- New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris
- Grade II or greater peripheral vascular disease
- CVA within 6 months of study entry
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Treatment (combination chemotherapy)
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8.
Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
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IV gegeven
Andere namen:
IV gegeven
Andere namen:
IV gegeven
Andere namen:
IV gegeven
Andere namen:
IV gegeven
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Severe Adverse Event (SAE) Rate
Tijdsspanne: The duration of the study
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The primary objective is to evaluate safety in all treated patients specifically the rate of serious adverse events which were defined as grade 5 events, grade 4 hemorrhage or thrombosis or bowel perforation
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The duration of the study
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Progression Free Survival Rate
Tijdsspanne: From randomization to the first documented disease progression
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From randomization to the first documented disease progression
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Allyson Ocean, Montefiore Medical Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
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
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Pathologische processen
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Ziekte attributen
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Colon Ziekten
- Darmziekten
- Intestinale neoplasmata
- Rectale ziekten
- Colorectale neoplasmata
- Neoplasmata, cysteus, slijmerig en sereus
- Herhaling
- Adenocarcinoom
- Rectale neoplasmata
- Cystadenocarcinoom
- Koloniale neoplasmata
- Adenocarcinoom, slijmerig
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Beschermende middelen
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Micronutriënten
- Vitaminen
- Tegengif
- Vitamine B-complex
- Antilichamen
- Fluoruracil
- Oxaliplatine
- Immunoglobulinen
- Bevacizumab
- Leucovorin
- Levoleucovorine
- Antilichamen, monoklonaal
- Antineoplastische middelen, immunologisch
- Cetuximab
Andere studie-ID-nummers
- NCI-2012-03006
- N01CM62201 (Subsidie/contract van de Amerikaanse NIH)
- N01CM62204 (Subsidie/contract van de Amerikaanse NIH)
- NCI-6490 (Andere identificatie: CTEP ID)
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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