- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00454571
Pazopanib Hydrochloride After Leuprolide Acetate or Goserelin Acetate in Treating Patients With Relapsed Prostate Cancer
A Randomized, Phase II Study of GW786034 (Pazopanib) in Stage D0 Relapsed Androgen Sensitive Prostate Cancer Following Limited GnRH Agonist Therapy
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Determine if pazopanib hydrochloride is able to increase time to progression, as measured by prostate-specific antigen (PSA), after 6 months of limited gonadotropin-releasing hormone (GnRH) agonist therapy comprising leuprolide acetate or goserelin in patients with androgen-sensitive relapsed stage D0 prostate cancer.
SECONDARY OBJECTIVES:
I. Determine the adverse events in patients treated with this regimen. II. To monitor for changes in testosterone in relationship to pazopanib therapy versus observation.
OUTLINE:
Patients receive androgen blockade comprising GnRH agonist therapy (e.g., leuprolide acetate or goserelin acetate) for 6 months. Patients who develop metastases or have PSA progression while on GnRH agonist therapy are removed from the study and placed on total androgen blockade. The remaining patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo observation.
After completion of study treatment, patients are followed up periodically for up to 12 months.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60637-1470
- University of Chicago Comprehensive Cancer Center
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53792
- University of Wisconsin Hospital and Clinics
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Histologically or cytologically confirmed prostate cancer
- Stage D0
- Must have undergone some definitive local therapy for prostate cancer
- Must be free of macrometastatic disease, as evidenced by computed tomography (CT) scan and bone scan, if serum PSA ≥ 10 ng/mL prior to GnRH agonist therapy
Progressive disease meeting the following criteria: NOTE: Patients who have undergone a prostatectomy and have two detectable, rising serum PSA levels are eligible
- Two consecutive rises in PSA above nadir recorded after definite local therapy
- Serum PSA concentrations must have absolute value of > 0.5 ng/mL (separated by ≥ 2 weeks) prior to beginning GnRH agonist therapy
- PSA < 0.5 ng/mL
- Testosterone < 30 ng/mL
- No measurable disease
- No brain metastases requiring steroid or anticonvulsant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60- 100%
- Prothrombin time (PT)/international normalization ratio (INR)/partial thromboplastin time (PTT) ≤ 1.2 times upper limit of normal (ULN)
- Bilirubin normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance > 50 mL/min
- Proteinuria ≤ 1+ on 2 consecutive dipsticks > 1 week apart
- Urine protein: creatinine ratio < 1 OR urine protein < 1.0 g/24 hours
- Fertile patients must use effective double-barrier contraception during study therapy OR completely abstain from sexual intercourse 14 days prior to, during, and for ≥ 21 days after completion of study therapy
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or to other agents used in the study
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Psychiatric illness or social situations that would preclude compliance with study requirements
- No human immunodeficiency virus (HIV) positivity
No condition that impairs the ability to swallow and retain pazopanib hydrochloride tablets, including any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication
- Requirement for intravenous (IV) alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
No other conditions, including any of the following:
- Serious or nonhealing wound, ulcer, or bone fracture
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- Cerebrovascular accident within the past 6 months
- Myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the past 6 months
- Venous thrombosis within the past 12 weeks
New York Heart Association (NYHA) class III or IV heart failure
- History of currently treated asymptomatic NYHA class II heart failure allowed
Systolic blood pressure (BP) ≤ 140 mm Hg and diastolic BP ≤ 90 mm Hg
- Prior initiation or adjustment of BP medication allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 140/90 mm Hg
- More than 3 months since prior antiandrogen
- More than 4 months since prior orchiectomy or implantable luteinizing LHRH agonist
No prior GnRH agonists except for neoadjuvant or adjuvant therapy associated with local therapy
Patients who have started a GnRH agonist for micrometastatic disease after local therapy allowed provided the following criteria are met:
- Progressive disease
- Willing to discontinue therapy before 6 months have elapsed
- Have signed consent prior to completing 6 months of the initial hormone therapy
- Are within 4 months of initiating GnRH agonist therapy
- No prior or concurrent GnRH antagonist therapy
- No concurrent ketoconazole
No concurrent cytochrome P450 2C9 (CYP2C9) substrates, including any of the following:
Anticoagulants (e.g., warfarin [therapeutic doses only])
- Low molecular weight heparin or prophylactic low-dose warfarin allowed
- Oral hypoglycemics (e.g., glipizide, glyburide, tolbutamide, glimepiride, or nateglinide)
- Ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, or methylergonovine)
- Neuroleptics (e.g., pimozide)
- Erectile dysfunction agents (e.g., sildenafil, tadalafil, or vardenafil)
- Antiarrhythmics (e.g., bepridil, flecainide, lidocaine, mexiletin, amiodarone, quinidine, or propafenone)
- Immune modulators (e.g., cyclosporine, tacrolimus, or sirolimus)
- Miscellaneous medications (e.g., theophylline, quetiapine, risperidone, tacrine, clozapine, or atomoxetine)
No concurrent medications associated with the risk of QTc prolongation and/or Torsades de Pointes
- Replacement of drugs that do not carry these risks allowed
- No other concurrent non-Food and Drug Administration (FDA)-approved agents
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Pazopanib
Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate.
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
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Dato PO
Altri nomi:
Altri nomi:
Altri nomi:
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Comparatore attivo: Observation
Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
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Altri nomi:
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Median Time to PSA Progression
Lasso di tempo: Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment
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The median time to disease progression for the therapy and observation groups will be estimated using the Kaplan-Meier estimate and compared using the log-rank test.
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Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Median PSA Progression-free Survival
Lasso di tempo: Time from randomization to PSA progression or death from any cause
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Kaplan-Meier estimates for PSA progression-free survival will be computed for the pazopanib and active surveillance groups and compared using the log rank test.
The outcome measure is median PSA progression-free survival time.
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Time from randomization to PSA progression or death from any cause
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Edwin Posadas, University of Chicago Comprehensive Cancer Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie genitali, maschio
- Malattie della prostata
- Neoplasie prostatiche
- Effetti fisiologici delle droghe
- Agenti antineoplastici
- Agenti antineoplastici, ormonali
- Agenti di controllo riproduttivo
- Agenti di fertilità, femmina
- Agenti di fertilità
- Leuprolide
- Goserelin
Altri numeri di identificazione dello studio
- NCI-2009-00202
- N01CM62201 (Sovvenzione/contratto NIH degli Stati Uniti)
- CDR0000538086 (Identificatore di registro: PDQ (Physician Data Query))
- 14954A
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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