NCT00022620已完成2 期
Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)
European Organisation for Research and Treatment of Cancer - EORTC16 个研究点 分布在 6 个国家开始时间: 2001年6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
- 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.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.
详细描述
OBJECTIVES:
- Determine the therapeutic activity of paclitaxel in patients with refractory or recurrent endometrial papillary carcinoma.
- Determine the objective response and duration of response in patients treated with this regimen.
- Determine the acute side effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)
- •Progressive or recurrent
- •Bidimensionally measurable disease
- •Platinum refractory disease, defined by one of the following:
- •Progression during platinum-based chemotherapy
- •Stable disease for at least 4 courses of platinum-based chemotherapy
- •Recurrence within 4 months of platinum-based chemotherapy
- •No brain involvement or leptomeningeal disease
- •PATIENT CHARACTERISTICS:
- •75 and under
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 50 umol/L
- •BUN no greater than 8.0 mmol/L
- •Creatinine no greater than 120 umol/L
- •Creatinine clearance at least 60 mL/min
- •Not pregnant
- •Fertile patients must use effective contraception
- •HIV negative
- •No other prior or concurrent malignancy except basal cell carcinoma of the skin
- •No active bacterial infection (e.g., urinary tract infection)
- •No uncontrolled or potentially active site of infection (e.g., fistula or abscess)
- •No psychological, familial, sociological, or geographical condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •At least 1 prior platinum containing regimen
- •At least 50 mg/m2 per course for a maximum of 28 days for cisplatin
- •At least 5 times AUC for a maximum of 4 weeks per course for carboplatin
- •Prior non-taxane-containing chemotherapy allowed
- •Endocrine therapy:
- •At least 4 weeks since prior hormonal therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •At least 3 months since prior radiotherapy to target lesion
- •Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field)
- •Prior surgical management of lymph nodes allowed
排除标准
- 未提供
研究者
研究点 (16)
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