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Cediranib Maleate With or Without Gefitinib in Treating Patients With Recurrent or Progressive Glioblastoma

2. mai 2017 oppdatert av: University College, London

Multi-Center, Randomized, Double-Blind Phase II Study Comparing Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo in Subjects With Recurrent/Progressive Glioblastoma (DORIC Trial)

RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cediranib maleate given together with gefitinib is more effective than cediranib maleate given alone in treating patients with recurrent or progressive glioblastoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib maleate together with gefitinib and to see how well it works compared with giving cediranib maleate together with a placebo in treating patients with recurrent or progressive glioblastoma.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • To compare progression-free survival, overall survival, radiological response, and safety and tolerability of cediranib maleate in combination with gefitinib versus cediranib maleate in combination with a placebo in patients with recurrent or progressive glioblastoma following standard front-line treatment.

OUTLINE: This is a multicenter study.

Patients receive cediranib maleate and gefitinib or cediranib maleate and a placebo once daily on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected from some patients for genetic profiling and biomarker analysis.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Studietype

Intervensjonell

Registrering (Faktiske)

38

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
      • Birmingham, Storbritannia
        • Queen Elizabeth Hospital
      • Bristol, Storbritannia
        • Bristol Haematology and Oncology Centre
      • Cambridge, Storbritannia
        • Addenbrooke's Hospital
      • Guildford, Storbritannia
        • Royal Surrey County Hospital
      • Hull, Storbritannia
        • Castle Hill Hospital
      • London, Storbritannia
        • Charing Cross Hospital
      • Manchester, Storbritannia
        • The Christie NHS Foundation Trust
      • Southampton, Storbritannia
        • Southampton General Hospital
      • Sutton, Storbritannia
        • Royal Marsden Hospital
    • England
      • London, England, Storbritannia, NW1 2BU
        • University College Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 120 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed glioblastoma
  • Measurable disease by MRI

  • Completed standard first-line treatment for glioblastoma including surgery (unless not received due to anatomical location), radiotherapy and temozolomide (last dose given at least 28 days prior to enrollment)

    • No other prior treatment for glioblastoma except Gliadel or steroids

  • Recurrent or progressive disease after standard first-line treatment

    • No disease progression within 3 months of completion of radiotherapy
  • No intra- or peri-tumoral hemorrhage

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Mini-mental status score ≥ 15
  • Life expectancy ≥ 12 weeks
  • Serum bilirubin, ALT/AST, creatinine, and urine protein normal
  • Adequate bone marrow reserve
  • Not pregnant or nursing
  • Normal ECG
  • No history of familial long QT syndrome
  • No absorption or swallowing difficulties
  • No uncontrolled hypertension or cardiac ventricular arrhythmias
  • No current or history of uncontrolled hypertension or requiring maximal doses of calcium channel blockers
  • No severe or uncontrolled disease
  • No history of lung disease
  • No recent hemorrhage or hemoptysis
  • No known hypersensitivity to cediranib maleate, gefitinib, or any excipients
  • No history of other malignancies except adequately treated basal cell or squamous cell carcinoma or carcinoma in situ within the past 5 years, unless disease-free for 2 years with tissue diagnosis
  • No known HIV positivity
  • No known hepatitis B or C infection
  • No unhealed surgical incision
  • Not involved in planning or conducting this study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior anticancer therapy, including radiotherapy
  • At least 3 months since prior cranial radiation
  • At least 30 days since prior investigational drugs
  • At least 28 days since prior craniotomy
  • At least 2 weeks since prior enzyme-inducing antiepileptic drugs
  • At least 2 weeks since prior and no concurrent dexamethasone (> 8 mg/day) or equivalent
  • At least 14 days since prior major surgery or brain biopsy
  • No concurrent steroids OR on stable dose 5 days prior to baseline MRI
  • No other concurrent anticancer therapy, except for steroids (dexamethasone only)
  • No previous enrollment on the current study
  • No prior inhibitors of angiogenesis, EGFR, or downstream targets
  • No prior radiosurgery or brachytherapy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Cediranib & Gefitinib
Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
Legemiddel: gefitinib
Legemiddel: cediranib maleat
Placebo komparator: Cediranbib & placebo
Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
Legemiddel: Placebo
Legemiddel: cediranib maleat

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free Survival
Tidsramme: from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken)

Progression free survival (PFS) defined as the time from the date of randomisation to the date of first progression or death due to any cause, whichever one comes first.

The progression definition will be based on modified RANO criteria (Wen 2010), such that progression will be defined as the earliest time that at least one of the following occurs:

  1. Clinical deterioration

  2. Failure to return for evaluation as a result of death or deteriorating condition

    Or, by retrospective radiographic central review:

  3. Any new lesion
  4. Increase in ≥25% of sum of the products of perpendicular diameters of enhancing lesions compared with baseline scan, on stable or increasing doses of steroids (dexamethasone) compared to baseline (T1 post-contrast scan)
  5. Clear progression of non-measureable disease
  6. Significant increase in T2/FLAIR non-enhancing lesion - on stable or increasing steroids (dexamethasone) compared with baseline or best response not caused by co-morbid events.
from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken)

Sekundære resultatmål

Resultatmål
Tidsramme
Overall Survival
Tidsramme: from date of randomization to date of Death due to any cause.
from date of randomization to date of Death due to any cause.
Radiographic Response Rate
Tidsramme: from baseline scan to six week and 12 week scans
from baseline scan to six week and 12 week scans
Progression-free Survival Rate at 6 Months
Tidsramme: from the date of randomisation to 6 months
from the date of randomisation to 6 months
Steroid Use
Tidsramme: from randomization to first increase in dexamethasone dose
from randomization to first increase in dexamethasone dose
Time to Deterioration of Neurological Status
Tidsramme: from date of randomization to the date of first neurological status worsening in comparison to baseline (first of 2 confirmatory reports at 2 consecutive visits, 6 weeks apart) as assessed by the clinician, or until date of death, whichever is first.
from date of randomization to the date of first neurological status worsening in comparison to baseline (first of 2 confirmatory reports at 2 consecutive visits, 6 weeks apart) as assessed by the clinician, or until date of death, whichever is first.
Safety and Tolerability
Tidsramme: from date of randomisation to death
from date of randomisation to death

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University College, London

Samarbeidspartnere

AstraZeneca

Etterforskere

  • Hovedetterforsker: Paul Mulholland, PhD, MRCP, MSC, MBBS, University College London Hospitals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2011

Primær fullføring (Faktiske)

1. mai 2013

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

5. mars 2011

Først innsendt som oppfylte QC-kriteriene

5. mars 2011

Først lagt ut (Anslag)

9. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mai 2017

Sist bekreftet

1. mai 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000696313
  • UCL-10/0035
  • ZENECA-ISSRECE00002
  • EUDRACT-2010-021531-13
  • CRUKE/10/044

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