Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium
A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel and cisplatin works in treating patients with advanced transitional cell cancer of the urothelium.
研究概览
详细说明
OBJECTIVES:
- Determine response to gemcitabine hydrochloride, paclitaxel, and cisplatin (GTP) among patients with regional or distant metastases of transitional cell carcinoma of the urothelium or local/regional recurrence after cystoprostatectomy.
- Determine response in patients who receive GTP as the initial chemotherapeutic treatment as well as in patients who have received prior chemotherapy.
- Determine response duration, freedom from progression, and overall survival.
- Assess the toxicity of GTP.
OUTLINE: This is an open-label study. Patients are stratified according to prior chemotherapy (yes vs no).
Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a partial response or complete response undergo surgical restaging and debulking. Four to 6 weeks later, patients receive 2 additional courses of chemotherapy.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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North Carolina
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Charlotte、North Carolina、美国、28203-4239
- Carolinas Hematology-Oncology Associates
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Greensboro、North Carolina、美国、27403-1199
- Regional Cancer Center
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Winston-Salem、North Carolina、美国、27157-1096
- Wake Forest University Comprehensive Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, or ureter) or TCC with squamous or glandular elements
- No pure squamous cell carcinoma or adenocarcinoma
- Disease not amenable to local curative treatment
Regional or distant metastases of TCC of the urothelium OR local/regional recurrence after cystectomy, cystoprostatectomy, nephroureterectomy, or ureterectomy
- If regional metastases present alone, histological confirmation of the metastases is required
- No clinically evident brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 1.6 mg/mL
- Bilirubin ≤ 1.8 mg/mL
- SGOT ≤ 3 times upper limit of normal
- Life expectancy > 3 months
- No known sensitivity to E. coli-derived products
- No other prior or concurrent malignancy except active/inactive nonmelanoma skin cancer, adequately treated stage I or II cancer currently in complete remission, or observation-only early-stage prostate cancer
- No other serious medical illness that would limit survival to < 3 months
- No psychiatric condition that would limit compliance with study requirements
- No active uncontrolled bacterial, viral, or fungal infection unless corrected or controlled
- No hemorrhagic disorder
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy regimen
- Prior intravesical therapy allowed
- Prior definitive radiation to renal pelvis, ureter, or bladder allowed
- No concurrent chemotherapy with nonstudy drugs
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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毒性
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总生存期
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响应持续时间
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回复
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免于进步
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合作者和调查者
调查人员
- 学习椅:Frank M. Torti, MD, MPH、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CCCWFU-88197
- CDR0000466059 (注册表标识符:PDQ (Physician Data Query))
- CCCWFU-BG98-217
- AMGEN-CCCWFU-88197
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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