NCT00064610已完成1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 7
研究概览
简要总结
The purpose of this study is to evaluate how safe PS-341(VELCADE) is when given with Docetaxel (Taxotere) to patients with androgen-independent prostate cancer, and also to see what effects (good and bad) it has on you and on your cancer.
详细描述
This is a dose escalation study, which means that the first group of patients will receive a low dose of PS-341 (VELCADE) and Docetaxel (Taxotere). If the low dose of VELCADE and Taxotere appears to be safe, then the next group of patients will receive a higher dose of VELCADE and Taxotere.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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/mm
- •Platelets greater than or equal to100,000/mm
- •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).]
排除标准
- •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
- •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.
研究者
研究点 (7)
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