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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
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Illinois
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Chicago、Illinois、アメリカ、60637-1470
- University of Chicago Comprehensive Cancer Center
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- University of Wisconsin Hospital and Clinics
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
|
与えられたPO
他の名前:
他の名前:
他の名前:
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アクティブコンパレータ:Observation
Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
|
他の名前:
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Median Time to PSA Progression
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Median PSA Progression-free Survival
時間枠:Time from randomization to PSA progression or death from any cause
|
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.
|
Time from randomization to PSA progression or death from any cause
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協力者と研究者
捜査官
- 主任研究者:Edwin Posadas、University of Chicago Comprehensive Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2009-00202
- N01CM62201 (米国 NIH グラント/契約)
- CDR0000538086 (レジストリ識別子:PDQ (Physician Data Query))
- 14954A
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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