Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer
A Phase I/II, Open Label, Dose Escalation Study to Determine the Tolerance and Preliminary Activity of PS-341 Plus Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer Requiring Chemotherapy
調査の概要
詳細な説明
研究の種類
入学
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90048
- Cedars Sinai Medical Center
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New York
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New York、New York、アメリカ、10032
- Columbia-Presbyterian Hospital
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt University Medical Center
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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
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Patient has histologically-confirmed advanced and/or metastatic androgen-independent prostate cancer requiring anti-neoplastic treatment.
- Previous or concurrent hormone therapy with a luteinizing hormone-releasing hormone analog (e.g., leuprolide) does not preclude enrollment in the study.
Patient has progressive measurable or evaluable disease, defined as meeting at least one of the following three criteria [1]:
- Progressive measurable disease (changes in the size of lymph nodes or parenchymal masses on physical examination or x-ray).
- Progressive bone metastasis [presence of new lesion(s) on a bone scan].
Progressive PSA, as evidenced by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement.
- If the third measurement is not greater than the second measurement, then a fourth measurement must be taken; the fourth measurement must be greater than the second measurement for the patient to be eligible for enrollment in the study.
- The confirmatory PSA measurement (i.e., the third or, if applicable, fourth PSA measurement) must be greater than or equal to 5 ng/mL.
- Patient is 18 years of age or older.
- Patient has a Karnofsky performance status of 60% or greater.
- Patient has a life expectancy of three months or longer.
- Patient has all of the following pretreatment laboratory data within 14 days before the first study drug dose:
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3.
- Platelets greater than or equal to100,000/mm3.
- Hemoglobin >8.0 g/dL.
- Serum creatinine less than or equal to 2.5 mg/dL.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
- Patient agrees to use an acceptable barrier method for contraception from Screening through 90 days after the last study drug dose. [It is recommended that female partners of male patients enrolled in this study also use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence).]
Exclusion criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- Patient has received chemotherapy within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment.
- Patient has received radiation therapy within four weeks of enrollment.
- Patient has not recovered from all toxic effects of previous chemotherapy or radiation or antibody therapy.
- Patient received treatment with flutamide within four weeks of enrollment or nilutamide or bicalutamide within six weeks of enrollment.
- Patient has had any major surgery within four weeks of enrollment.
- Patient has a history of allergic reactions to diuretics or anti-emetics suggested to be administered in conjunction with study drug
- Patient has a history of severe hypersensitivity reaction to docetaxel or other agents formulated with polysorbate 80.
- Patient had a myocardial infarction within six months of enrollment or has uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia
- Patient has uncontrolled brain metastases or central nervous system disease.
- Patient has Grade 2 or higher peripheral neuropathy
Patient has any of the following pretreatment laboratory data within 14 days before the first study drug dose:
- Total bilirubin > than the upper limit of normal (ULN).
- Alanine transaminase (ALT) and/or aspartate transaminase (AST) >1.5 x the ULN concurrent with alkaline phosphatase >2.5 x the ULN.
- Alkaline phosphatase >5 x the ULN, unless shown by fractionation to be bone-derived and AST, ALT, bilirubin, gamma glutamyl transferase (GGT), and 5'nucleotidase are <1.5 x the ULN and bilirubin is within normal range.
- Serum testosterone 50 ng/mL or higher.
- Patient is HIV-infected.
- Patient is hepatitis B surface antigen positive or has previously documented hepatitis C infection.
- Patient has an uncontrolled intercurrent illness (e.g., active infection).
- Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
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:非ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:なし(オープンラベル)
協力者と研究者
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
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