NCT00084565撤回2 期
Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel, topotecan, and estramustine.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
Secondary
- Determine the frequency and number of circulating tumor cells in patients before and after treatment with this regimen and at disease progression.
- Determine the microtubule morphology, β-tubulin isotype pattern, apoptotic markers, and metaphase chromosome alignment in circulating tumor cells in patients before and after treatment with this regimen and at disease progression.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate gland
- •Progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases)
- •Radiologic evidence of hydronephrosis alone dose not constitute metastatic disease
- •Failed prior primary hormonal therapy (e.g., estrogen therapy, luteinizing hormone-releasing hormone blocker and flutamide) or bilateral orchiectomy
- •Patients previously treated with flutamide or bicalutamide must have evidence of disease progression i.e., increasing Prostate-Specific Antigen (PSA)
- •PSA level ≥ 10 ng/mL if bone metastases only are present (i.e., lacking measurable soft tissue disease)
- •No elevated serum acid phosphatase or PSA level as the only evidence of disease
- •No carcinomatous meningitis or brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •White Blood Cell (WBC) ≥ 4,000/mm^3 OR
- •Granulocyte count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Serum Glutamic-Oxaloacetic Transaminase(SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2 times normal
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine ≤ 2.0 mg/dL OR
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •History of deep venous thrombosis allowed provided patients are maintained on therapeutic anticoagulation therapy
- •No active angina pectoris
- •No New York Heart Association class II-IV heart disease
- •No myocardial infarction within the past 6 months
- •No thrombosis within the past 3 months
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No active infection
- •No other concurrent serious medical illness that would preclude study participation
- •No other malignancy within the past 3 years except curatively treated basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •At least 4 weeks since prior flutamide
- •At least 8 weeks since prior bicalutamide
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
- •See Disease Characteristics
- •Recovered from all prior therapy
- •No prior cytotoxic therapy for prostate cancer
- •No concurrent milk, milk products, antacids, calcium-containing drugs, or food during estramustine administration
排除标准
- 未提供
研究者
相似试验
已完成
2 期
Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical CancerCervical CancerNCT00276796Gynecologic Oncology Group66
终止
2 期
Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast CancerRecurrent Breast CancerStage IV Breast CancerBreast CancerNCT01009983Wake Forest University Health Sciences14
已完成
2 期
Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine CancerSarcomaNCT00112489Gynecologic Oncology Group55
终止
2 期
Paclitaxel and Celecoxib in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00084448Gynecologic Oncology Group
撤回
1 期
Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00009828University of Pittsburgh