NCT00025220已完成2 期
A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Frequency and severity of adverse effects as assessed by CTC
研究概览
简要总结
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine leiomyosarcoma.
II. Determine the nature and degree of the toxicity of this drug in these patients.
III. Determine the partial and complete response rates in patients treated with this drug.
IV. Determine the duration of PFS and overall survival of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed primary uterine leiomyosarcoma (LMS) that is refractory to curative therapy or established treatments
- •Recurrent or persistent disease
- •At least 1 unidimensionally measurable target lesion
- •At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
- •Tumors within a previously irradiated field are considered non-target lesions
- •No smooth muscle tumor of uncertain malignant potential, including metastatic or recurrent disease from such a tumor
- •Must have received 1 prior initial chemotherapy regimen (including high-dose, consolidation, or extended therapy after surgical or nonsurgical assessment) for uterine LMS
- •Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active phase III protocol for the same patient population
- •No documented brain metastases since diagnosis of cancer
- •Patients with stable CNS deficits are allowed provided there are no brain metastases, as confirmed by CT scan or MRI
- •Performance status - GOG 0-2 if received 1 prior therapy regimen
- •Performance status - GOG 0-1 if received 2 prior therapy regimens
- •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
- •Creatinine clearance greater than 60 mL/min
- •No documented seizure disorders since diagnosis of cancer
- •Patients with a history of seizure disorders are allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months)while on an appropriately monitored treatment regimen
- •No active infection requiring antibiotics
- •No greater than grade 1 sensory or motor neuropathy
- •No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use at least 1 highly active method and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation
- •No prior thalidomide
- •At least 3 weeks since prior immunologic agents for uterine LMS
- •At least 3 weeks since other prior chemotherapy for uterine LMS and recovered
- •No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine LMS
- •No prior non-cytotoxic chemotherapy for recurrent or persistent uterine LMS
- •At least 1 week since prior hormonal therapy for uterine LMS
- •Concurrent hormone replacement therapy allowed
- •At least 3 weeks since prior radiotherapy for uterine LMS and recovered
- •No prior radiotherapy to more than 25% of bone marrow
- •Recovered from recent prior surgery
- •No prior anticancer therapy that would preclude study therapy
- •At least 3 weeks since other prior therapy for uterine LMS
- •No concurrent bisphosphonates (e.g., zoledronate)
排除标准
- 未提供
研究组 & 干预措施
Treatment (thalidomide)
Experimental
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (thalidomide)
Experimental
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Thalidomide (Drug)
结局指标
主要结局
Frequency and severity of adverse effects as assessed by CTC
时间窗: Up to 7 years
Progression-free survival
时间窗: 6 months
次要结局
- Duration of progression-free survival(Up to 7 years)
- Duration of overall survival(Up to 7 years)
- Frequency of clinical response (partial and complete response)(Up to 7 years)
研究者
研究点 (1)
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