A Phase II, Single-arm Study of Docetaxel and Oxaliplatin in Metastatic Cisplatin-resistant Transitional Cell Carcinoma of the Urinary Bladder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable objective response rate, time to disease progression and survival were also assessed.
详细描述
This non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable objective response rate, time to disease progression and survival were also assessed.
Treatment was administered on an outpatient basis. No other concurrent therapy for malignant disease was administered. Patients received both docetaxel and oxaliplatin, IV on day 1 of each cycle. Treatment will be repeated every 21 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or treatment delay > 3 weeks.
All patients should receive antiemetics prior to treatment. An oral or IV 5-HT3 receptor antagonist in combination with a benzodiazepene and Decadron was recommended. To mitigate docetaxel associated hypersensitivity reactions, Decadron was administered at a dose of 8mg bid, 1 day prior to, the day of, and the day after administration of docetaxel (total of 3 days)
Day 1 of each cycle:
Docetaxel was administered at a dose of 60mg/m2 IV infusion, followed by oxaliplatin at a dose of 110mg/m2 as a 2 hour IV infusion. Oxaliplatin solution was further diluted in an infusion solution of 250 mL to 500 mL Dextrose 5% in Water (D5W). Oxaliplatin was be capped at a maximum BSA of 2.0
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed transitional cell carcinoma of the Urothelial tract.
- •Confirmed metastatic disease.
- •Measurable progressive disease is required.
- •18 years of age. Because no dosing or adverse event data are currently available on the use of oxaliplatin in patients < 18 years of age, they are excluded from this study.
- •Life expectancy of greater than 6 months.
- •ECOG Performance status of 0-
- •Must have received prior treatment with standard of care chemotherapy No more than 2 prior regimens of cytotoxic chemotherapy.
- •No other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment.
- •Patients must have acceptable organ function as defined below:
- •Hematopoietic: WBC > 2500/mm3 or ANC > 1500/mm3, hemoglobin > 9.0 g/dL, platelet count > 100,000/mm3 Hepatic: Bilirubin < 1.5 mg/dL, SGOT/SGPT < 2 x ULN (< 4 x ULN if liver metastases present) Renal: Creatinine < 1.8 mg/dL
- •Adequate neurologic function defined as no clinically significant peripheral neuropathy, defined as any neuropathy ≤ grade
- •Adequate cardiovascular function defined as no active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months.
排除标准
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •No prior therapy with oxaliplatin is allowed.
- •No history of allergic reactions attributed to the drugs used in this study or compounds of similar chemical or biologic composition.
- •No history of intolerance or allergy to the antiemetics to be administered in conjunction with the study drugs (i.e., 5 HT3 antagonists).
- •No concurrent other active cancer from another primary site, except squamous cell and basal cell carcinoma of the skin.
- •No other serious concomitant illness will be allowed, including interstitial pneumonia, extensive and symptomatic fibrosis of the lung, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, NYHA Class III or IV, serious cardiac arrhythmia, uncontrolled diabetes mellitus or active infection.
研究组 & 干预措施
Docetaxel and Oxaliplatin
Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
干预措施: Docetaxel (Drug)
Docetaxel and Oxaliplatin
Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Response Rate
时间窗: Up to 4 years
Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.
次要结局
- Time to Progression (TTP)(Up to 4 years)
- Overall Survival(Up to 4 years)
- Disease Control Rate (DCR)(Up to 4 years)
研究者
Leonard Appleman
Principal Investigator
University of Pittsburgh