Docetaxel, Doxorubicin, and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Assess prostate specific antigen response rate to docetaxel, doxorubicin hydrochloride, and prednisone in patients with hormone-refractory advanced prostate cancer.
Secondary
- Assess if treatment with docetaxel, doxorubicin hydrochloride, and prednisone will improve health-related quality of life of these patients.
- Assess the toxicity of docetaxel, doxorubicin hydrochloride, and prednisone.
- Assess response rate in measurable disease.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, doxorubicin hydrochloride IV over 15 minutes on days 1 and 8, and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, after completion of 3 courses, and at disease progression.
After completing study treatment, patients are followed every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
研究の種類
入学 (予想される)
段階
- フェーズ2
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
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with any of the following:
- Prostate-specific antigen ≥ 10 mg/dL
- Bone disease
- Bidimensional soft tissue disease
- Evaluable disease
- Advanced disease AND failed prior primary androgen ablation therapy, including anti-androgen withdrawal
- Disease not amenable to local curative treatment
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine < 2.0 mg/dL
- SGPT and SGOT < 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ ULN
- Hemoglobin ≥ 10 g/dL
- Ejection fraction ≥ 50%
- Peripheral neuropathy ≤ grade 1
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No previous history of or concurrent malignancy, except for any of the following:
- Inactive nonmelanoma skin cancer
- Disease-free for five or more years
- Adequately treated stage I or II cancer from which patient is currently in complete remission
- No other serious medical illness that would limit survival to less than 3 months
- No psychiatric condition that would prevent informed consent
- No active, uncontrolled bacterial, viral, or fungal infection
- No hemorrhagic disorder
- No history of severe hypersensitivity reaction to other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No new hormonal treatment within the past 4 weeks
- No prior immunotherapy, chemotherapy, or bone-seeking radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
- Prior bisphosphonates allowed
- At least 2 weeks since prior radiotherapy
- No other concurrent chemotherapy
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
- マスキング:なし(オープンラベル)
協力者と研究者
捜査官
- スタディチェア:Frank M. Torti, MD, MPH、Wake Forest University Health Sciences
研究記録日
主要日程の研究
研究開始
一次修了 (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
- CCCWFU-85302
- CDR0000466318 (レジストリ識別子:PDQ (Physician Data Query))
- CCCWFU-BG04-264
- AVENTIS-CCCWFU-85302
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。
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