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- Klinische proef NCT00574769
Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer
9 april 2017 bijgewerkt door: University of Southern California
Phase Ib/II Evaluation of RAD001 With Docetaxel and Bevacizumab in Patients With Metastatic Androgen Independent Prostate Cancer
Prostate cancer is a common and important health issue.
Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable.
The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones (androgens) required for growth.
Although this treatment is successful for many patients, the cancer may eventually return in others.
Recurrent prostate cancer may be treated with additional hormonal agents, but these agents usually do not result in long-term control of the disease.
Eventually most patients with recurrent prostate cancer progress to a state where the cancer grows despite very low level of circulating male hormones known as androgen independent prostate cancer (AIPC).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Patients will undergo a screening procedure to determine eligibility of trial.
During the treatment period, the patient will be given docetaxel/bevacizumab on day 1 followed by RAD001 continuously on days 2-21 and this is called a treatment cycle.
Patients will be able to continue to receive multiple treatment courses as long as the cancer does not get worse and the person does not develop other problems that would prevent him from staying in the study.
The final part of the research is the study completion period which includes an end of treatment visit and subsequent follow-up visits.
These visits take place whenever the research medication is stopped, even if it is stopped early.
For the patient's safety, he/she should at least complete the end of treatment visit.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
27
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Beverly Hills, California, Verenigde Staten, 90211
- Westside Prostate Cancer Center, University of Southern California
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Los Angeles, California, Verenigde Staten, 90033
- USC/Norris Comprehensive Cancer Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
Inclusion Criteria:
- Age ≥ 18 years.
- Signed informed consent
- ECOG performance status: 0-2
- Histologically documented adenocarcinoma of the prostate
- Progressive disease despite androgen deprivation therapy. Progressive disease is defined as any one of the following:
- Measurable Disease: Objective evidence of increase > 20% in the sum of the longest diameters of target lesions from the time of maximal regression or the appearance of one or more new lesions (Modified RECIST Criteria)
- Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer
- PSA Progression: An elevated PSA (≥ 5 ng/ml) which has risen serially from baseline on two occasions each at least one week apart
- At least 4 weeks since any other hormonal therapy. Flutamide and megestrol acetate (any dose) must be discontinued at least 4 weeks prior to initiating treatment. Bicalutamide or nilutamide must be discontinued at least 6 weeks prior to initiating treatment. If improvement following antiandrogen withdrawal is noted, progression must be established using the criteria above. Androgen suppression should be continued
- ≥ 4 weeks since major surgery and fully recovered
- ≥ 8 weeks since high risk surgery and fully recovered
- ≥ 4 weeks since any prior radiation and fully recovered
- ≥ 6 weeks since the last dose of bone targeted radiopharmaceutical
- Men of child-bearing potential are required to use an effective means of contraception
Required Initial Laboratory Values:
- ANC ≥ 1500/µL
- Platelet count ≥ 100,000/µL
- Creatinine ≤ 1.5 x ULN
- Bilirubin ≤ 1.5 x ULN
- AST ≤ 1.5 x ULN
- Urine protein to creatinine ratio < 1.0
- Serum Testosterone ≤ 50 ng/dL (For patients who have not had bilateral orchiectomy.)
Exclusion Criteria:
- Prior treatment with cytotoxic chemotherapy for metastatic disease
- Prior treatment with anti-angiogenic agents, including thalidomide and bevacizumab
- Prior treatment with any investigational drug within 4 weeks of initiating treatment
- Prior treatment with an mTor inhibitor
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Known history of HIV seropositivity
- Known brain metastases (brain imaging is not required)
- Congestive heart failure
- Uncontrolled hypertension. Patients with history of hypertension must be well controlled (< 150/100) on a regimen of anti-hypertensive therapy
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Active bleeding diathesis or on oral anti-vitamin K medications (except low dose coumarin)
- Arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), at any time
- History of unstable angina or angina requiring surgical or medical intervention in the past 12 months, or myocardial infarction (MI)
- Patients with clinically significant peripheral artery disease or any other arterial thrombotic event
- Significant vascular disease
- Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- Proteinuria at screening as demonstrated by either
- Urine protein:creatinine (UPC) ratio ≥ 1.0 OR
- Urine dipstick for proteinuria ≥ 2+
- Serious or non-healing wound, ulcer or bone fracture
- Peripheral neuropathy ≥ grade 2
- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- Herbal medications and food supplements must be discontinued before registration. Patients may continue on daily vitamins and calcium supplements
- History of noncompliance to medical regimens
- Unwilling to or unable to comply with the protocol
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 1
|
RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily Bevacizumab infusion (IV), 15 mg/kg every 21 days Docetaxel infusion (IV), 75 mg/m^2 every 21 days
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab
Tijdsspanne: After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab
|
After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Evaluate the efficacy of RAD001 in combination with docetaxel/bevacizumab as determined by best overall response and progression-free survival in patients with advanced prostate cancer.
Tijdsspanne: overall survival
|
overall survival
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Mitchell E Gross, MD, Ph.D, University of Southern California
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
17 februari 2010
Primaire voltooiing (Werkelijk)
17 februari 2016
Studie voltooiing (Werkelijk)
17 februari 2017
Studieregistratiedata
Eerst ingediend
14 december 2007
Eerst ingediend dat voldeed aan de QC-criteria
14 december 2007
Eerst geplaatst (Schatting)
17 december 2007
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 april 2017
Laatste update ingediend die voldeed aan QC-criteria
9 april 2017
Laatst geverifieerd
1 april 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Genitale neoplasmata, mannelijk
- Prostaat Ziekten
- Prostaatneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Docetaxel
- Bevacizumab
- Everolimus
Andere studie-ID-nummers
- 4P-09-4
- AVF3955s
- CRAD001CUS2468
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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German Breast GroupAGO Study GroupVoltooid
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Rabin Medical CenterOnbekendVergevorderde maagkankerIsraël
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-
The Netherlands Cancer InstituteOnbekendUitgezaaide maagkanker | Adenocarcinoom van de gastro-oesofageale overgangNederland
-
Memorial Sloan Kettering Cancer CenterVoltooidCarcinoom, niet-kleincellige longVerenigde Staten
-
Qingdao Central HospitalVoltooidProgressievrije overlevingChina
-
The First Affiliated Hospital of Xinxiang Medical...Nog niet aan het werven
-
PharmatechSanofi; Genentech, Inc.BeëindigdNiet-kleincellige longkanker stadium IIIB | Niet-kleincellige longkanker stadium IV
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University of PittsburghGenentech, Inc.; Novartis PharmaceuticalsVoltooidEierstokkanker | Eileiderkanker | Primair peritoneaal carcinoomVerenigde Staten