NCT00471718终止1 期
A Phase1/2 Trial of ABT-751 in Patients With Advanced, Androgen-Independent Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-751 and to see how well it works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
详细描述
OBJECTIVES:
Primary
- Evaluate the safety and efficacy of ABT-751 in patients with androgen-independent, hormone-refractory metastatic prostate cancer and determine the maximum tolerated dose (MTD) and optimal phase II dose of this drug in these patients.
Secondary
- Determine the objective response rate (partial and complete response) in patients with measurable disease treated with this drug.
- Evaluate the effect of this drug on prostate-specific antigen (PSA) response in patients with nonmeasurable disease.
- Determine the time to tumor progression in patients treated with this drug.
- Determine survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients at least 18 years of age.
- •Patients must have histologically proven adenocarcinoma of the prostate gland.
- •Patients must have metastatic disease (e.g. bone metastases, pelvic mass, nodal, liver or lung metastases), with evidence of radiographic progression (including bone scans observed during last treatment) or serologically -Patients with bone-only metastases (i.e. lacking soft tissue or visceral disease) must have a PSA level > 10 ng/mls. Patients with soft tissue metastases and/or visceral disease must have either measurable disease OR a PSA level > 10 ng/ml.
- •Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g. LHRH therapy, estrogens, etc.) with evidence of treatment failure and simultaneous documentation of a castrate testosterone level (< 50 ng/dL) NOTE: Patients who have not undergone bilateral orchiectomy must continue LHRH agonist therapy for the duration of this protocol unless this medically contraindicated.
- •For patients previously treated with flutamide, nilutamide, or bicalutamide: patients must have discontinued flutamide or nilutamide > 4 weeks prior to randomization (> 6 weeks for bicalutamide) with no evidence of an anti-androgen withdrawal response (i.e. no decline in serum PSA and/or no improvement in baseline scans).
- •Patients must have received prior therapy with docetaxel alone or in combination with either prednisone or estramustine. This therapy may have been given in a neoadjuvant, adjuvant or metastatic setting
- •Patients must not have received radiotherapy < 3 weeks prior to randomization. If patients have received prior radiotherapy to an evaluable lesion(s), there must be evidence of radiographic progression prior to entry.
- •Patients must not have received prior Strontium 89, Samarium 153, or other therapeutic radioisotopes.
- •Patients must have recovered from all systemic toxicities due to prior treatment for prostate cancer (does not include incontinence, impotence, etc. secondary to primary therapy)
- •The patient must have an ECOG Performance Status of 0-1
- •The patient must have adequate hematologic, renal and hepatic function as follows:
- •Hematologic: ANC > 1200/mm3; hemoglobin > 9.0 g/dl; platelets > 100,000/mm3
- •Renal: serum creatinine < 2.0 mg/dL
- •Hepatic: bilirubin < 2.5 mg/dL; AST and ALT < 2.5X upper limit of normal (ULN); < 5X ULN for patients with hepatic metastases
- •Sexually-active patients must use a contraceptive method deemed acceptable by the investigator while in the study and for up to 3 months following completion of therapy.
- •The patient or the patient's legally acceptable representative has voluntarily signed and dated an informed consent approved by and Institutional Review Board prior to any study any study specific procedures.
- •Patients may be receiving bisphosphonate therapy prior to randomization and continue while receiving protocol therapy, but must not begin treatment with bispohosphonates while receiving protocol therapy. Patients on bisphosphonates must have completed at least 4 weeks of bisphosphonate therapy prior to entry onto study.
- •Patients with a history of a prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for the specific malignancy.
排除标准
- •No active angina pectoris, uncontrolled hypertension, or known heart disease of New York Heart Association Class III-IV. Patients must not have a history of myocardial infarction, congestive cardiac failure (New York Heart Association Class 3), or coronary angioplasty/stenting < 6 months prior to entry.
- •No carcinomatous meningitis or brain metastases.
- •Any investigational therapy within 4 weeks.
- •No serious concurrent medical illness or active infection, which, in the opinion of the investigator, would jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety.
- •Documented history of allergy to sulfa medications.
- •Current colchicines treatment
- •Greater than Grade 1 CTC neurology category findings (Appendix A).
- •Prior treatment with more than 1 prior chemotherapy regimen.
研究组 & 干预措施
Phase I/II: Chemotherapy ABT-751
Experimental
Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21.
Phase II: Patients receive ABT-751 twice daily
干预措施: ABT-751 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: up to four weeks
MTD is determined by the 3+3 study design, in which patients are enrolled in cohorts of 3. In any dose cohort, if 1 patient of 3 experience dose-limiting toxicity (DLT), three additional patients will be enrolled at the same dose level. Whenever \>=2 of 6 subjects experience a DLT, then the maximum tolerated dose (MTD) has been exceeded. The MTD is generally one dose below that at which DLT occurs in \>= 2 of 6 subjects in any given cohort.
Number of Patients Who Demonstrated Treatment Effectiveness Based on Prostate Specific Antigen (PSA) Response in Non-measurable Disease
时间窗: after four weeks
Patients with a minimum 50% decline in PSA from pre-treatment baseline, confirmed by a second PSA 4 or more weeks later, measured in nanograms per milliliter of blood.
次要结局
- Number of Patients With Objective Response (CR & PR) by RECIST(after four weeks)
- Median Time to Tumor Progression(date on study to date of progression)
- Overall Survival(date on study to date of death from any cause)
- Safety Profile Based on Number of Patients With Worst Grade Toxicities(at 30 days after final treatment dose)
研究者
Jeffrey A. Sosman, MD
Professor of Medicine; Director, Melanoma and Tumor Immunotherapy
Vanderbilt-Ingram Cancer Center
研究点 (1)
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