A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
18 januari 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants With Adverse Events
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants Who Died
Tidsram: Baseline up to approximately 3 years
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Baseline up to approximately 3 years
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Duration of Survival
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2005
Primärt slutförande (Faktisk)
1 oktober 2007
Avslutad studie (Faktisk)
1 april 2008
Studieregistreringsdatum
Först inskickad
12 oktober 2015
Först inskickad som uppfyllde QC-kriterierna
20 oktober 2015
Första postat (Uppskatta)
21 oktober 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 januari 2017
Senast verifierad
1 januari 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Neoplastiska processer
- Kolorektala neoplasmer
- Neoplasma Metastas
- Kolonneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Topoisomerasinhibitorer
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Topoisomeras I-hämmare
- Fluorouracil
- Oxaliplatin
- Bevacizumab
- Irinotekan
Andra studie-ID-nummer
- ML18436
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .