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A Phase II Study Investigating Upfront Pazopanib In Metastatic Renal Cancer Renal Cancer (Panther) (Panther)

11. juni 2014 opdateret af: Centre of Experimental Medicine, Queen Mary University of London

A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)

The purpose of this study is to investigate if 14 weeks of pazopanib therapy prior to surgery (nephrectomy) is of benefit to patients with metastatic renal cancer. Ninety-five patients will be recruited into his study.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

This is a Phase II, open label study evaluating pre-operative pazopanib treatment in previously untreated patients with metastatic clear cell renal cancer. This study follows a Simon 2 stage design

Patients will take pazopanib for 14 weeks followed by a nephrectomy. The drug will continue after nephrectomy until disease progression is documented. Patients will come off study once disease progression occurs, where they will then be followed for survival. Subsequent treatment at the discretion of the treating physician will be documented.

After surgery, all patients will be radiologically evaluated 8 weekly until progression. Standard radical nephrectomy with lymph node dissection will be performed on those patients who are deemed operable. The surgery can be laparoscopic or open. Those not deemed suitable for nephrectomy after 14 weeks of treatment will be offered a repeat biopsy.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

95

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • Basildon, Det Forenede Kongerige
        • Basildon and Thurrock University Hospitals NHS Foundation Trust
      • Coventry, Det Forenede Kongerige
        • University Hospitals Coventry & Warwickshire NHS Trust
      • Glasgow, Det Forenede Kongerige
        • The Beatson West of Scotland Cancer Centre
      • London, Det Forenede Kongerige
        • Barts and London Hospital NHS Trust
      • London, Det Forenede Kongerige
        • Oncology & Clinical Haematology Trials Unit, Royal Free Hospital
      • London, Det Forenede Kongerige
        • Oncology & Haematology Clinical Trials Unit, Guy's Hospital
      • Oxford, Det Forenede Kongerige
        • Department of Oncology Oxford Cancer Centre
      • Southampton, Det Forenede Kongerige
        • Southampton General Hospital
      • Southend, Det Forenede Kongerige
        • Southend University Hospital Trust

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

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The study population for this trial are patients with confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST). Only a component of clear cell is required.

Beskrivelse

Inclusion Criteria:

  • Histopathologically confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST v1.1). Only a component of clear cell is required.

    • No prior systemic treatment or nephrectomy for RCC. Palliative radiotherapy is acceptable to non target lesions.

    • Adequate organ function as defined by the following criteria:

      i. Total serum bilirubin ≤1.5 x uln (patients with gilbert's disease exempt) ii. Serum transaminases (ALT) <3 x uln iii. Calculated creatinine clearance >30ml/min iv. Absolute neutrophil count (ANC) ≥1000/mm3 without growth factor support v. Platelets ≥ 75,000/mm3

    • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
    • Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
    • ECOG performance status of 0, 1 or 2.
    • 18 years or above (no upper age limit) Male or female

Exclusion Criteria:

  • Congestive heart failure (class III or IV NYHA), myocardial infarction or coronary artery bypass graft/ stenting or stroke in the previous six months, ongoing severe or unstable arrhythmia requiring medication.

    • Previous treatment for renal cancer
    • Pregnancy or breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use adequate contraception during the period of therapy.
    • Male patients must be surgically sterile or agree to use adequate contraception during the period of therapy.
    • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would in the judgement of the investigator, impart excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
    • Prolonged QT interval >480msecs or a history of prolonged QT interval >480msecs
    • Ongoing major gastrointestinal disease including ulcerative colitis, bleeding peptic ulcer disease or inflammatory bowel disease.
    • Bleeding diathesis
    • Current uncontrolled hypertension
    • Another malignancy requiring treatment within the last 5 years. Local prostate cancer not requiring hormone therapy or an asymptomatic raised PSA is acceptable.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria
Tidsramme: Interim analysis after 34 patients have 12 weeks of treatment
12 week CT scan will be compared to the baseline CT scan using RESIST criteria 1.1 to assess whether the patients have benefited from the upfront pazopanib treatment.
Interim analysis after 34 patients have 12 weeks of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Surgical complications (blood loss, post operative complications, hospital stay)
Tidsramme: After the first 20 patients have had a nephrectomy
Following surgery information regarding the quantity of blood loss, time the surgery took, length of hospital stay and whether there were any surgical complications will be recorded.
After the first 20 patients have had a nephrectomy
Overall Survival
Tidsramme: After three years of study
Overall survival will be measured from start of treatment to time of death.
After three years of study
Progression free survival
Tidsramme: After all patients have progresssed
Progression free survival will be measured from start of study treatment to time of disease progression.
After all patients have progresssed
Local response of primary tumour to pazopanib
Tidsramme: After 12 weeks of study drug
After 12 weeks of study drug

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Queen Mary University of London

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. juli 2010

Primær færdiggørelse (Faktiske)

1. februar 2014

Studieafslutning (Forventet)

1. december 2014

Datoer for studieregistrering

Først indsendt

4. oktober 2011

Først indsendt, der opfyldte QC-kriterier

13. januar 2012

Først opslået (Skøn)

19. januar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2009-016675-29

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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