NCT00014274已完成2 期
Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy
European Organisation for Research and Treatment of Cancer - EORTC29 个研究点 分布在 11 个国家目标入组 238 人开始时间: 2001年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 29
- 主要终点
- Duration of survival
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 tumor cells. It is not yet known which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium.
PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.
详细描述
OBJECTIVES:
- Compare the antitumor activity of gemcitabine and carboplatin vs methotrexate, carboplatin, and vinblastine in patients with transitional cell cancer of the urothelium who are ineligible for cisplatin-based chemotherapy.
- Compare the toxicity and acute and intermediate (1-2 years) side effects of these regimens in these patients.
- Compare the complete response rates, progression-free survival, and overall survival of patients treated with these regimens.
- Compare the symptoms and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive methotrexate* IV and vinblastine IV on days 1, 15, and 22 and carboplatin IV over 1 hour on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: * Methotrexate is omitted for patients with pleural effusion or ascites until complete resolution and for patients with a glomerular filtration rate less than 30 mL/min or creatinine greater than 2 mg/dL
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed transitional cell cancer of the urothelium, including the renal pelvis, ureters, urinary bladder, and urethra, meeting 1 of the following criteria:
- •Unresected positive lymph node
- •Distant metastases (M1, stage IV)
- •Unresectable primary bladder cancer (T3-4)
- •Measurable disease
- •Ineligible for cisplatin-based chemotherapy and presenting with the following:
- •WHO performance status 2 AND/OR
- •Glomerular filtration rate greater than 30 mL/min but less than 60 mL/min
- •No brain metastases or other CNS lesions
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •See Disease Characteristics
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 125,000/mm^3
- •Bilirubin no greater than 1.25 times normal
- •AST/ALT no greater than 3 times normal (5 times normal if liver metastases are present)
- •See Disease Characteristics
- •Calcium normal
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 6 months after study participation
- •No psychological, familial, sociological, or geographical condition that would preclude study participation
- •No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior systemic biologic therapy
- •Chemotherapy:
- •See Disease Characteristics
- •No prior systemic cytotoxic therapy (including adjuvant and neoadjuvant chemotherapy)
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 3 months since prior radiotherapy
- •Prior radiotherapy to study lesions allowed if there is evidence of disease progression
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Duration of survival
次要结局
- Response as assessed by RECIST criteria
- Toxicity as assessed by CTC v2
研究者
研究点 (29)
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