Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer
BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)
調査の概要
詳細な説明
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care).
This protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. PSA response rate, tumor margin status and pathologic responses were assessed.
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
-
-
Rhode Island
-
Providence、Rhode Island、アメリカ、02906
- Miriam Hospital
-
-
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:
- Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine or transitional cell carcinomas are not eligible.
- All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.
- Clinically Localized Disease: Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:
- Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes > 1 cm: or endorectal MRI(If one or more lymph nodes(s) measures > 1 cm, a negative biopsy is required.)
- Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if necessary).(Positive PET and Prostascint scans are not considered proof of metastatic disease.)
Patients must have high risk disease defined as either:
- Gleason Score 8-10
- PSA > 15 ng/ml
- Stage T3a
- Stage T2c and Gleason score of 7
- Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a single lobe.
- No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy.
- Patient must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by an urologist.
- ECOG PS 0-1
- Age > 18 years of age.
Required initial laboratory values:
- ANC > 1500/ul
- Platelet count > 100,000/mm3
- Creatinine < 2.0 mg/dl
- Serum PSA < 100 ng/ml
- Bilirubin < upper institutional limit of normal (ULN)
- AST/ALT < 2.5 X ULN
Exclusion Criteria:
- Active or uncontrolled infection.
- Patients must not have other coexistent medical condition that would preclude protocol therapy.
- Previous severe hypersensitivity reaction to a drug formulated in CremophoreL (polyoxyethylated castor oil).
- Grade 1 or greater neuropathy (motor or sensory) at study entry
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：なし
- 介入モデル：単一グループの割り当て
- 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：Ixabepilone
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study*** |
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
他の名前：
Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**
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 |
|---|---|---|
|
Prostate-Specific Antigen (PSA) Response
時間枠：after 12 weeks of ixabepilone
|
Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
|
after 12 weeks of ixabepilone
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Howard Safran, MD、BrUOG Study Chair
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。