NCT00005644已完成2 期
Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 16
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function.
详细描述
OBJECTIVES:
- Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium with renal insufficiency when treated with paclitaxel and gemcitabine.
- Determine the toxicity of this regimen in this patient population.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed progressive regional or metastatic transitional cell carcinoma of the urothelium
- •Mixed histologies containing a component of transitional cell carcinoma allowed
- •Bidimensionally measurable disease
- •No clinical evidence of CNS metastases
- •Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR
- •Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR
- •SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN
- •Creatinine no greater than 3.0 mg/dL
- •Glomerular filtration rate no greater than 50 mL/min
- •Cardiovascular:
- •No history of American Heart Association class III or IV heart disease
- •No uncontrolled congestive heart failure
- •No severe cardiac arrhythmias
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No preexisting peripheral neuropathy grade 2 or greater
- •No active unresolved infection requiring parenteral antibiotics within the past 7 days
- •No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior systemic biologic response modifier therapy for advanced disease
- •Prior intravesical BCG for superficial disease allowed
- •Chemotherapy:
- •Prior intravesical chemotherapy for superficial disease allowed
- •No prior chemotherapy for advanced disease
- •At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV), or cisplatin as a radiosensitizer
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior major surgery and recovered
- •No concurrent hemodialysis
排除标准
- 未提供
研究者
研究点 (16)
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