NCT00085332已完成2 期
A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 75
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).
详细描述
OBJECTIVES:
- Determine the antitumor activity of docetaxel in patients with recurrent or persistent endometrial carcinoma.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days 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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed endometrial carcinoma
- •Recurrent or persistent disease
- •Refractory to curative or standard therapy
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •At least 1 target lesion
- •Tumors within a previously irradiated field are not considered target lesions
- •Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
- •One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
- •Ineligible for a higher priority GOG protocol
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •SGOT ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No neuropathy (sensory and motor) ≥ grade 2
- •No active infection requiring antibiotics
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •At least 3 weeks since prior biologic or immunologic therapy for malignant tumor
- •No concurrent prophylactic growth factors
- •No concurrent prophylactic thrombopoietic agents
- •Chemotherapy
- •See Disease Characteristics
- •Recovered from prior chemotherapy
- •No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs)
- •Endocrine therapy
- •At least 1 week since prior hormonal therapy for malignant tumor
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy
- •See Disease Characteristics
- •Recovered from prior radiotherapy
- •Recovered from prior surgery
- •At least 3 weeks since other prior therapy for malignant tumor
- •No prior anticancer therapy that would preclude current protocol therapy
- •No concurrent amifostine or other protective reagents
排除标准
- 未提供
研究者
研究点 (75)
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