NCT00033709Unknown2 期
A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic, Locally Advanced or Unresectable Leiomyosarcoma
Herbert Irving Comprehensive Cancer Center2 个研究点 分布在 1 个国家开始时间: 2002年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
- 主要终点
- Response (complete and partial response)
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. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic, locally advanced, or unresectable leiomyosarcoma.
详细描述
OBJECTIVES:
- Determine the efficacy of temozolomide and thalidomide in patients with metastatic, locally advanced, or unresectable leiomyosarcoma.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the clinical and laboratory toxic effects and tolerability of this regimen in these patients.
OUTLINE: Patients receive oral temozolomide once daily for 7 days every other week and oral thalidomide once daily. Treatment continues for up to 26 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 7.5-25 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed leiomyosarcoma
- •Metastatic, locally advanced, or unresectable
- •Ineligible for other high priority national or institutional study
- •At least 1 unidimensionally measurable lesion documented on radiologic study
- •At least 2 cm by 2 cm
- •Not previously irradiated unless disease progression at the site is evident
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 2 months
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Neutrophil count at least 1,500/mm^3
- •Platelet count greater than 70,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin less than upper limit of normal (ULN)
- •SGOT or SGPT less than 1.5 times ULN*
- •Alkaline phosphatase less than 2 times ULN* NOTE: * Less than 5 times ULN if documented liver disease
- •Creatinine less than 1.5 times normal OR
- •Creatinine clearance greater than 60 mL/min
- •BUN less than 1.5 times normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study therapy
- •No acute infection requiring systemic antibiotics
- •No frequent vomiting or medical condition that would preclude intake of oral medication (e.g., partial bowel obstruction)
- •No other serious medical or psychiatric illness that would preclude study participation
- •No prior malignancy except curatively treated carcinoma in situ of the cervix or skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •No more than 3 prior systemic chemotherapy regimens for metastatic, locally advanced, or unresectable leiomyosarcoma
- •Prior dacarbazine allowed
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •No prior radiotherapy to 50% or more of bone marrow
- •Concurrent radiotherapy for local control or palliative therapy for painful bony or soft tissue lesion allowed
- •At least 4 weeks since prior surgery and recovered
- •Recovered from all prior therapies
- •No other concurrent investigational drugs
排除标准
- 未提供
结局指标
主要结局
Response (complete and partial response)
次要结局
- Time to progression
- Clinical benefit
- Overall survival
研究者
研究点 (2)
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