Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer
A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.
研究概览
详细说明
OBJECTIVES: I. Determine the activity of cisplatin and vinorelbine in terms of response rate, duration of response, time to treatment failure, and survival in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.
OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes on days 1, 8, 15, and 22 and cisplatin IV over 4 hours beginning after completion of vinorelbine infusion on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within approximately 20 months.
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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California
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Orange、California、美国、92868
- Chao Family Comprehensive Cancer Center
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Hawaii
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Honolulu、Hawaii、美国、96813
- MBCCOP - Hawaii
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Maryland
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Baltimore、Maryland、美国、21231
- Johns Hopkins Oncology Center
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Michigan
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Ann Arbor、Michigan、美国、48106
- CCOP - Ann Arbor Regional
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New York
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Albany、New York、美国、12208
- Cancer Center of Albany Medical Center
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North Carolina
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Winston-Salem、North Carolina、美国、27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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South Carolina
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Spartanburg、South Carolina、美国、29303
- CCOP - Upstate Carolina
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Tennessee
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Nashville、Tennessee、美国、37203
- Brookview Research, Inc.
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Texas
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Houston、Texas、美国、77030
- University of Texas - MD Anderson Cancer Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS: Histologically proven advanced, persistent, or recurrent squamous cell carcinoma of the cervix that failed local therapy and is considered incurable Bidimensionally measurable abdominal, pelvic, or other lesion by palpation, x- ray, or ultrasound If sole site of measurable disease previously irradiated, then documented disease progression at that site required
PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Karnofsky 60%-100% Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 50 mL/min if creatinine greater than 1.2 mg/dL Other: No clinically significant infection No preexisting, clinically significant peripheral neuropathy unless due to cancer No other prior or concurrent malignancy except nonmelanomatous skin cancer No psychological, familial, sociological, or geographical condition that would preclude compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except for radiosensitization Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Recovered from the toxic effects of any recent radiotherapy Surgery: Recovered from the toxic effects of any recent surgery
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
合作者和调查者
调查人员
- 学习椅：Mitchell Morris, MD、M.D. Anderson Cancer Center
出版物和有用的链接
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 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.