NCT00071929已完成2 期
Phase II Evaluation of Oxaliplatin 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
- 76
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of oxaliplatin in terms of response rate in patients with persistent or recurrent endometrial carcinoma that is refractory to curative or established therapy.
- Determine the nature and degree of toxicity of this treatment regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 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.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed endometrial carcinoma that is refractory to curative therapy or established treatment
- •Clinically and/or histologically confirmed persistent or recurrent disease
- •Measurable disease by physical examination or medical imaging
- •Sonography allowed if lesions are clearly defined on initial examination and bidimensionally measurable
- •Ascites or pleural effusions not considered measurable
- •Must have received 1 prior cytotoxic therapy regimen
- •May include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
- •1 additional noncytotoxic regimen allowed
- •Biologic or cytostatic agents include, but are not limited to:
- •Monoclonal antibodies
- •Cytokines
- •Small-molecule inhibitors of signal transduction
- •Ineligible for a higher priority GOG protocol
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •GOG 0-2 if received 1 prior therapy regimen
- •GOG 0-1 if received 2 prior therapy regimens
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- •No sensory or motor neuropathy greater than grade 1
- •No residual neuropathy attributed to prior chemotherapy or other chronic conditions (e.g., diabetes, venous stasis, or carpal tunnel syndrome)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of allergy to platinum compounds or antiemetics
- •No active infection requiring antibiotics
- •No other uncontrolled illness
- •No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •At least 14 days since prior pegfilgrastim
- •At least 24 hours since other prior growth factors
- •At least 3 weeks since prior biologic or immunologic therapy
- •No concurrent growth factors during first course of study therapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and recovered
- 另有 11 项未显示
排除标准
- 未提供
研究者
研究点 (76)
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