NCT00058448终止2 期
Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 49
- 主要终点
- Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have locally advanced or metastatic penile cancer.
详细描述
OBJECTIVES:
- Determine the confirmed complete and partial response rate in patients with locally advanced or metastatic epidermoid carcinoma of the penis treated with docetaxel.
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
OUTLINE: Patients receive docetaxel IV over 15-30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3-5.8 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed epidermoid carcinoma of the penis
- •Distant metastases (M1) OR
- •Pathologically confirmed regional nodal metastases (N1-3)
- •Measurable disease
- •Soft tissue disease irradiated within the past 2 months is not considered measurable disease
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Zubrod 0-2
- •Life expectancy
- •Not specified
- •Hematopoietic
- •White blood cell (WBC) count at least 3,000/mm^3
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •Aspartate aminotransferase (SGOT) no greater than 2.5 times ULN
- •If SGOT is greater than ULN, alkaline phosphatase must be no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 4 times ULN
- •If alkaline phosphatase is greater than ULN, SGOT must be no greater than 1.5 times ULN
- •Not specified
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission
- •No grade 2 or greater peripheral neuropathy
- •No hypersensitivity to drugs formulated with polysorbate 80 (e.g., recombinant interferon alfa-2a, multivitamin infusion, etoposide, infliximab, or NovoSeven factor)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for penile cancer
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 28 days since prior radiotherapy and recovered
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment
时间窗: up to 24 weeks during treatment
次要结局
- Safety as measured by Common Terminology Criteria for Adverse Events (CTC) Version 3.0 every 4 weeks(up to 24 weeks during treatment)
研究者
研究点 (49)
Loading locations...
相似试验
已完成
2 期
Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal CancerPeritoneal Cavity CancerOvarian CancerNCT00004081Beth Israel Deaconess Medical Center30
已完成
2 期
Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)Endometrial CancerNCT00085332Gynecologic Oncology Group
已完成
2 期
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast CancerBreast CancerNCT00004906Hackensack Meridian Health
已完成
2 期
Docetaxel With or Without Thalidomide in Treating Patients With Metastatic Prostate CancerStage IV Prostate CancerAdenocarcinoma of the ProstateRecurrent Prostate CancerNCT00020046National Institutes of Health Clinical Center (CC)
已完成
2 期
Docetaxel in Treating Patients With Stage IV Prostate CancerPainProstate CancerNCT00003781OHSU Knight Cancer Institute25