- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01264341
Efficacy and Safety of Bevacizumab/Temsirolimus Combination to Treat Advanced Renal Cell Carcinoma
13. februar 2017 oppdatert av: Hellenic Cooperative Oncology Group
Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Temsirolimus, After 1st Line Anti-VEGF Treatment in Patients With Advanced Renal Cancer
The purpose of this study is to determine whether the combination of bevacizumab/temsirolimus is effective in patients with advanced renal carcinoma progressing after anti-VEGF treatment
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
39
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Athens, Hellas, 11528
- General Peripheral Hospital of Athens "Alexandra"
-
Athens, Hellas, 18547
- Metropolitan Hospital, 1st Dept of Medical Oncology
-
Athens, Hellas, 18547
- Metropolitan Hospital, 2nd Dept of Medical Oncology
-
Athens, Hellas, 14564
- Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology
-
Athens, Hellas, 11527
- General Hospital of Athens "Hippokratio"
-
Athens, Hellas, 14564
- Agii Anargiri Cancer Hospital, 2nd Dept of Medical Oncology
-
Rio, Patras, Hellas, 26500
- University Hospital of Patras
-
Thessaloniki, Hellas, 56429
- Papageorgiou General 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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adult patients (18th year of age completed)
- Signed and dated written informed consent form prior to any procedures related to this protocol.
- Histologically confirmed advanced clear cell renal cancer.
- Measurable disease.
- Failure of first line anti-VEGF treatment.
- Performance status 0-2, according to Eastern Cooperative Oncology Group (ECOG) .
Satisfactory hematological parameters:
- White blood cell count > 4000 mm3.
- Platelet count 100000/mm3.
- Neutrophil blood cell count > 1200/ mm3 .
- Hemoglobin > 9,0 g/dL (can be achieved with red blood cell transfusion).
Satisfactory biochemical parameters:
- Serum creatinine < 2 x Upper Limit of Normal(ULN)
- Aspartate Aminotransferase (AST)<2,5 x ULN
- Alanine Transaminase (ALT)< 2,5 x ULN.
- Bilirubin <2 x ULN
- (For female patients) Absence of pregnancy (negative pregnancy test for women of reproductive age before enrollment).
- (For female patients) Non-lactating women.
- Use of efficient contraceptive measures (women and men) to prevent possible pregnancy of female patient or female partner of a male patient during treatment and until 6 months after the end of treatment.
Exclusion Criteria:
- Prior treatment with mTOR inhibitor.
- Major surgery (including open biopsy) or insufficient recovery or existence of major trauma within 4 weeks before enrollment.
- Uncontrolled hypertension.
- Active infection requiring systemic treatment within 4 weeks prior to enrollment.
- Minor surgery (for instance, catheter placement) within 2 days before enrollment.
- Scheduled major surgery within the treatment period.
- Medical history in the last 6 months prior to enrollment of significant cardiovascular disease, diabetes, cardiac infarction, unstable angina, uncontrolled arrhythmia or significant heart failure.
- Indications of uncontrolled metastases or disease progression in CNS lesions (the suspicion of uncontrolled metastases or disease progression should be eliminated by imaging techniques within 14 days prior to enrollment).
- Medical history in the last 5 years prior to enrollment of any other malignancies (excluding the basal or squamous skin cell carcinoma or in situ carcinoma of the cervix).
- History of non-healing wound including active gastric ulcer.
- History of fistula in the last 6 months prior to enrollment.
- History of gastrointestinal perforations.
- Patient incapacity (for psychiatric or social reasons) to conform with the protocol.
- History of hemorrhagic predisposition.
- History of hypersensitivity to the medications under investigation.
- Significant proteinurea.
- Prior immunotherapy within 4 weeks prior to enrollment.
- Prior radiation treatment within 2 weeks prior to enrollment.
- Concomitant medication with inducers or strong inhibitors of the coenzyme CYP3A4 (see Appendix 5 for an indicative list of active compounds).
- Concurrent participation in other interventional clinical trials with investigational medicinal products.
- History of chronic interstitial lung disease.
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Bevacizumab combined with temsirolimus
Bevacizumab 10mg/kg intravenous every 2 weeks Temsirolimus 25mg intravenous once weekly
|
Bevacizumab 10mg/kg intravenous every 2 weeks until disease progression, unacceptable toxicity or consent withdrawal.
Temsirolimus 25mg intravenous once weekly until disease progression, unacceptable toxicity or consent withdrawal.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
6-month Progression Free Survival (PFS)
Tidsramme: 32 months
|
Proportion of patients who are progression-free at 6month evaluation from treatment initiation
|
32 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Progression Free Survival (PFS)
Tidsramme: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
|
PFS will be calculated from date of treatment initiation until disease progression or death (whichever occurs first)
|
Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
|
Overall Survival (OS)
Tidsramme: 48 months
|
OS will be calculated from the date of treatment initiation to the date of death or last contact
|
48 months
|
Response Rate (RR)
Tidsramme: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
|
RR is defined as the overall percentage of patients with partial (PR) or complete response (CR).
The evaluation of responses will be performed according to RECIST criteria
|
Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
|
Tumor Shrinkage
Tidsramme: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
|
Tumor shrinkage will be computed using waterfall plots
|
Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
|
Adverse Events (AEs) of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.
Tidsramme: 3 years
|
Adverse Events will be graded according to the NCI CTCAE v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient
|
3 years
|
Quality of Life (QoL) assessment
Tidsramme: At baseline and every 8 weeks during treatment
|
QoL will be assessed using the EORTC QLQ C-30 questionnaire.
The change in the QoL during treatment will be estimated using the Wilcoxon paired t-test
|
At baseline and every 8 weeks during treatment
|
Investigation of antiangiogenic factors (FGF, VEGF, VEGFRR)
Tidsramme: 36 months
|
Changes in serum levels of antiangiogenic factors during treatment and correlation to the outcome of study treatment.
|
36 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Aristotelis Bamias, MD, PhD, General Peripheral Hospital of Athens "Alexandra", Medical School, University of Athens
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.
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. desember 2010
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først innsendt
20. desember 2010
Først innsendt som oppfylte QC-kriteriene
20. desember 2010
Først lagt ut (Anslag)
21. desember 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. februar 2017
Sist bekreftet
1. februar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Nyresykdommer
- Urologiske sykdommer
- Nyre-neoplasmer
- Fysiologiske effekter av legemidler
- Anti-infeksjonsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Bevacizumab
- Sirolimus
Andre studie-ID-numre
- HE 21/10
- 2010-020664-38 (EudraCT-nummer)
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 Nyrekreft
-
Medical University of ViennaFullførtSekundær hyperparathyroidisme | CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder | NyreerstatningØsterrike
Kliniske studier på Bevacizumab
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeTilbakevendende egglederkarsinom | Tilbakevendende ovariekarsinom | Tilbakevendende primært peritonealt karsinom | Klarcellet ovariecystadenokarsinom | Endometrioid adenokarsinom på eggstokkene | Serøst cystadenokarsinom på eggstokkene | Endometrie klarcellet adenokarsinom | Endometrial serøst adenokarsinom og andre forholdForente stater
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RekrutteringTilbakevendende egglederkarsinom | Tilbakevendende ovariekarsinom | Tilbakevendende primært peritonealt karsinom | Endometrioid adenokarsinom på eggstokkene | Klarcellet adenokarsinom i eggstokkene | Adenokarsinom i egglederen | Serøst adenokarsinom i egglederen | Serøst adenokarsinom på eggstokkene | E... og andre forholdForente stater
-
National Cancer Institute (NCI)FullførtCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Livmorhalsplateepitelkarsinom, ikke spesifisert på annen måte | Stage IVA Livmorhalskreft AJCC v6 og v7 | Tilbakevendende livmorhalskreft | Stadium IV Livmorhalskreft AJCC v6 og v7 | Stadium IVB Livmorhalskreft AJCC v6 og v7Forente stater
-
National Cancer Institute (NCI)NRG OncologyFullførtBevacizumab med eller uten trebananib ved behandling av pasienter med tilbakevendende hjernesvulsterGlioblastom | Gliosarkom | Tilbakevendende glioblastom | Oligodendrogliom | Kjempecelleglioblastom | Tilbakevendende hjerneneoplasmaForente stater, Canada
-
M.D. Anderson Cancer CenterRekrutteringStage IB hepatocellulært karsinom AJCC v8 | Stage II hepatocellulært karsinom AJCC v8 | Resektabelt hepatocellulært karsinom | Stage I hepatocellulært karsinom AJCC v8 | Stage IA hepatocellulært karsinom AJCC v8Forente stater
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeStage IV kutant melanom AJCC v6 og v7 | Stage IIIC kutant melanom AJCC v7 | Uopererbart melanomForente stater
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeEndometrioid adenokarsinom på eggstokkene | Primært peritonealt høygradig serøst adenokarsinom | Endometrioid adenokarsinom i egglederen | Platina-resistent egglederkarsinom | Platina-resistent primært peritonealt karsinom | Ovarial høygradig serøst adenokarsinom | Platina-resistent ovariekarsinom | Eggleder...Forente stater, Canada
-
City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk lunge ikke-småcellet karsinom | Stage IVA lungekreft AJCC v8 | Stage IVB lungekreft AJCC v8 | Stadium III lungekreft AJCC v8 | Stadium IV lungekreft AJCC v8 | Stadium IIIA lungekreft AJCC v8 | Stadium IIIB lungekreft AJCC v8 | Stadium IIIC lungekreft AJCC v8 | Lokalt avansert ikke-småcellet... og andre forholdForente stater
-
Mayo ClinicNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeOndartet fast neoplasma | Endometrioid adenokarsinom på eggstokkene | Ovarialt udifferensiert karsinom | Cervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Ondartet peritoneal neoplasma | Endometrie klarcellet adenokarsinom | Endometrial Endometrioid Adenocarcinoma | Endometrie blandet celle adenokarsinom og andre forholdForente stater
-
Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsFullførtTilbakevendende egglederkarsinom | Tilbakevendende ovariekarsinom | Tilbakevendende primært peritonealt karsinom | Platina-resistent egglederkarsinom | Platina-resistent primært peritonealt karsinom | Platina-resistent ovariekarsinom | Ildfast ovariekarsinom | Ildfast egglederkarsinom | Refraktært primært...Forente stater