A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
18 januari 2017 bijgewerkt door: Hoffmann-La Roche
An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum.
The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Chai Yi, Taiwan, 613
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Kaohsiung, Taiwan, 00833
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Kaohsiung, Taiwan, 807
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Taichung, Taiwan, 404
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Taichung, Taiwan, 407
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Tainan, Taiwan, 704
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Tainan, Taiwan, 710
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Taipei, Taiwan, 104
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Previously untreated metastatic colon or rectal cancer
- Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment
Exclusion Criteria:
- Prior chemotherapy for metastatic colon or rectal cancer
- Planned radiotherapy for underlying disease
- Central nervous system metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start
- Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
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: Bevacizumab + Chemotherapy
Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study.
The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.
Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.
Andere namen:
Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.
Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants With Adverse Events
Tijdsspanne: Baseline up to approximately 3 years
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An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
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Baseline up to approximately 3 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants Who Died
Tijdsspanne: Baseline up to approximately 3 years
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Baseline up to approximately 3 years
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Duration of Survival
Tijdsspanne: Baseline up to approximately 3 years
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Duration of survival was defined as the time period from the start of first line therapy to death.
Duration of survival was estimated using Kaplan-Meier analysis.
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Baseline up to approximately 3 years
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Percentage of Participants With Disease Progression or Death
Tijdsspanne: Baseline up to approximately 3 years
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Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).
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Baseline up to approximately 3 years
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Progression-Free Survival Time
Tijdsspanne: Baseline up to approximately 3 years
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Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause.
Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL.
Progression-free survival was estimated using Kaplan-Meier analysis.
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Baseline up to approximately 3 years
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Number of Participants With Best Overall Response
Tijdsspanne: Baseline up to approximately 3 years
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The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL.
Complete response (CR): disappearance of all TL and non-TL.
If immunocytology was available, no disease was to be detected by that methodology.
Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry.
Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.
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Baseline up to approximately 3 years
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Mean Direct Medical Cost for Cancer Related Medical Care Utilization
Tijdsspanne: Baseline up to approximately 3 years
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Direct medical cost included cost of out-patient consultation and cost of hospitalization.
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Baseline up to approximately 3 years
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2005
Primaire voltooiing (Werkelijk)
1 oktober 2007
Studie voltooiing (Werkelijk)
1 april 2008
Studieregistratiedata
Eerst ingediend
12 oktober 2015
Eerst ingediend dat voldeed aan de QC-criteria
20 oktober 2015
Eerst geplaatst (Schatting)
21 oktober 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 maart 2017
Laatste update ingediend die voldeed aan QC-criteria
18 januari 2017
Laatst geverifieerd
1 januari 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Pathologische processen
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Colon Ziekten
- Darmziekten
- Intestinale neoplasmata
- Neoplastische processen
- Colorectale neoplasmata
- Neoplasma metastase
- Koloniale neoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Topoisomeraseremmers
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Topoisomerase I-remmers
- Fluoruracil
- Oxaliplatine
- Bevacizumab
- Irinotecan
Andere studie-ID-nummers
- ML18436
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