Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon
4. oktober 2021 opdateret af: NSABP Foundation Inc
Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors.
Without new blood vessels, the growth of a tumor is slowed.
Chemotherapy works to kill cancer cells directly.
This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI).
Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
7
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212
- NSABP Operations Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
- Evidence of adequate organ function (such as liver, kidneys, etc.)
Exclusion Criteria:
- Diagnosis of anal cancer
- Patients who are candidates for surgery
- Patients who have received previous treatments
- Pregnant or lactating women
- History of chronic disease(s) or other serious medical conditions
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
|
7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
Andre navne:
130 mg/m2 IV Day 1 every 21 days for eight cycles
Andre navne:
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
Andre navne:
|
|
Eksperimentel: 2
|
7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
Andre navne:
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
Andre navne:
200 mg/m2 IV Day 1 every 21 days for eight cycles
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
One-year Progression-free Survival (PFS)
Tidsramme: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Outcome measure was not assessed due to early study closure.
The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
|
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Objective Response Rate
Tidsramme: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
|
Toxicity - Adverse Events
Tidsramme: Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
|
Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
|
|
Overall Survival
Tidsramme: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
|
Duration of Response
Tidsramme: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2006
Primær færdiggørelse (Faktiske)
1. maj 2008
Studieafslutning (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først indsendt
11. april 2006
Først indsendt, der opfyldte QC-kriterier
11. april 2006
Først opslået (Skøn)
13. april 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. oktober 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. oktober 2021
Sidst verificeret
1. oktober 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Topoisomerasehæmmere
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Topoisomerase I-hæmmere
- Capecitabin
- Oxaliplatin
- Bevacizumab
- Irinotecan
Andre undersøgelses-id-numre
- NSABP FC-BV-003
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