- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00408252
Efficacy of SU 011248 in Head And Neck Carcinoma
A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This is an open-label phase II, multicenter study. Eligible patients will receive SU011248 in monotherapy (37.5 mg given continuously without interruption). Tumor check-up will be performed every 6-8 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator (the median for treatment in renal cell study was 8 months).
Since, head and neck tumors are easily accessible for iterative biopsy, this study will offer the opportunity to get tumor biopsies before and after SU011248. Our study will allow translational research with biopsies at crucial timing: at baseline before any treatment, , during the treatment with SU011248 (cycle 1, between week 4 and 6), for patients with stable disease or partial response, a new biopsy will be performed at the time of disease progression to try to understand the mechanisms of tumor or resistance.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
-
Bruxelles, Belgia, 1200
- Cliniques Universiatires St LUC UCL
-
Namur, Belgia, 5000
- Clinique Sainte Elisabeth
-
Yvoir, Belgia, 5004
- Clinique universiataire de Mont Godinnes UCL
-
-
-
-
-
Clermont Ferrand, Frankrike, 263011
- Centre Jean Perrin
-
DIJON Cedex, Frankrike, 8021079
- Centre G-F Leclerc
-
Nancy, Frankrike, 4511
- Centre Alexis Vautrin
-
Saint Herblain Cedex, Frankrike, 44805
- René Gauducheau
-
Tours cedex 1, Frankrike, 37044
- CHU Bretonneau
-
Villejuif Cedex, Frankrike, 94805
- Institut Gustave Roussy
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation
- Recurrence must be confirmed by anatomopathology (cytology or biopsy)
- At least one measurable lesion by MRI or CT-scan
- Failed or relapsing after first line chemotherapy including a platinum* or a taxane-based chemotherapy regimen
- Patients ineligible for chemotherapy could be included in first line
- ECOG performance status 0 -2, in stable medical condition
- Patients must be able to swallow tablets
- Patients must have an expected survival of at least 3 months
- Paraffin-embedded tumor tissue available for immunohistochemistry
- Patients must be over 18 years old and must be able to give written informed consent
- Women of child-bearing age must have a negative pregnancy test
- Female patients of child-bearing age must use effective contraception until 3 months have elapsed after the last injection
- Patients must have normal organ function
- For patients with local recurrence and easily accessible tumors, acceptance of iterative biopsies to store tumor samples (Formaldehyde for immunochemistry, RNA later)
- Acceptance of giving 20 ml of blood for eventual pharmacogenomic analysis
- Acceptance of giving two plasma samples (3ml) at baseline and after 4 weeks of treatment with SU011248
- Signed informed consent prior to beginning protocol specific procedure
Exclusion Criteria:
- Non-squamous head and neck cancer
- Nasopharynx cancer
- Brain metastases
- More than two lines of chemotherapy for palliative treatment (except if chemotherapy was given as a part of a multimodal treatment given with a curative intent)
- Surgery or irradiation or investigational drugs within 4 weeks before study inclusion
- Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, …)
- Active uncontrolled coronary disease or cardiac insufficiency (Ejection fraction below 40%)
- Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Other concomitant anticancer therapies
- Previous treatment with anti-VEGF, PDGF, or kit therapies. EGFR therapy is not an exclusion criteria.
- Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm A
patients will receive SU011248 in monotherapy
|
No intervention, only biopsy for translational project
no intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration)
Tidsramme: every 6 weeks
|
every 6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine the safety profile of SU011248 alone in patients with head and neck cancer.
Tidsramme: untill disaese progression
|
untill disaese progression
|
Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival.
Tidsramme: untill disease progression
|
untill disease progression
|
Translational research objective:To better understand the mechanisms of sunitinib resistance by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.
Tidsramme: at week 6 and at disaese progression after recist response
|
at week 6 and at disaese progression after recist response
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jean-Pascal H Machiels, MD PhD, Cliniques Universitaires St Luc
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer, kjertel og epitel
- Sykdomsattributter
- Karsinom
- Tilbakefall
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Proteinkinasehemmere
- Sunitinib
Andre studie-ID-numre
- GORTEC 2006-01
- IIR Study A6181004
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på biopsies
-
UNICANCERNational Cancer Institute, FranceAktiv, ikke rekrutterendeTrippel-negativ brystneoplasmaFrankrike
-
Centre Hospitalier Universitaire de NiceUkjentParodontitt Aggressiv | Parodontitt KroniskFrankrike
-
Duke UniversityFullførtInterstitiell lungesykdomForente stater
-
Bracco Diagnostics, IncBracco Imaging S.p.A.AvsluttetProstatakreftItalia, Østerrike, Frankrike, Nederland, Belgia, Tyskland, Storbritannia
-
Odense University HospitalHar ikke rekruttert ennåProstatakreft (diagnose)
-
Chandan SenAvsluttetSårbein | Ikke-diabetespasienter | Kronisk sår bein/fotForente stater
-
University of DundeeNHS Tayside; Chief Scientist Office of the Scottish Government; Prostate... og andre samarbeidspartnereFullførtProstatakreftStorbritannia
-
Heidelberg UniversityGerman Research FoundationFullført
-
Mayo ClinicAktiv, ikke rekrutterendeAmyloidose | Perifer nevropati | Kronisk inflammatorisk demyeliniserende polyradikulonevropati | Vaskulittisk nevropati (lidelse) | Arvelig nevropati | Sarcoid nevropatiForente stater
-
Azienda Unità Sanitaria Locale Reggio EmiliaGeneral ElectricRekrutteringBrystkreft | KalsifiseringItalia