NCT00006005已完成2 期
Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin
New York University Cancer Institute15 个研究点 分布在 1 个国家开始时间: 2000年9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
- 发起方
- 试验地点
- 15
研究概览
简要总结
RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.
详细描述
OBJECTIVES:
- Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.
- Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.
- Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.
OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed sarcoma or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin not amenable to resection or radiotherapy
- •Measurable disease
- •Lesions accurately measured in at least 1 dimension of at least 20 mm in longest diameter with conventional techniques or at least 10 mm with helical CT scan
- •Histologically or cytologically confirmed neoplastic nature if solitary lesion
- •No nonmeasurable disease, defined as:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Unconfirmed abdominal masses not followed by imaging techniques
- •Cystic lesions
- •Documented recurrence or persistence following appropriate surgery, radiotherapy, and/or chemotherapy
- •Postmenopausal or status post hysterectomy
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Granulocyte count at least 1,000/mm^3
- •Platelet count at least 50,000/mm^3
- •Bilirubin normal
- •Transaminases less than 2.5 times upper limit of normal
- •Creatinine less than 1.5 mg/dL
- •No grade 2 or greater peripheral neuropathy
- •No medical or social factors that would preclude study, including inability to take oral medication
- •No other serious illness requiring immediate therapy
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 30 days since any prior noncytotoxic experimental antiemetic or antifungal investigational drug
排除标准
- 未提供
研究者
研究点 (15)
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