NCT00023725已完成1 期
A Randomized Phase I/II Study Of Preoperative Radiotherapy With/Without SUGEN 5416 (NSC # 696819; A TK Inhibitor Anti-Angiogenesis Compound) In The Management Of Low To Intermediate Grade Soft Tissue Sarcoma Of The Trunk or Extremity
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 451
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if radiation therapy is more effective with or without SU5416 in treating soft tissue sarcoma.
PURPOSE: Phase I/II trial to compare the effectiveness of radiation therapy with or without SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of SU5416 when combined with neoadjuvant radiotherapy in patients with stage IB or IIA soft tissue sarcoma.
- Determine the antiangiogenic effects of SU5416 in these patients.
- Determine any synergistic antiangiogenic effect of SU5416 with radiotherapy in these patients.
- Compare the disease-free survival, local recurrence, distant metastases, and overall survival rates in patients treated with neoadjuvant radiotherapy with or without SU5416.
OUTLINE: This is a phase I dose-escalation study of SU5416 followed by a phase II randomized study.
Phase I:
- Patients undergo radiotherapy once daily, 5 days a week, for 5 weeks. Patients also receive SU5416 IV over 1 hour twice weekly beginning on week 1 and continuing until 2 days before surgery.
- Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 primary or locally recurrent stage IB or IIA soft tissue sarcoma
- •Grade 1 or 2
- •Tumor greater than 5 cm in diameter
- •Tumor located on upper extremities (including shoulder), lower extremities (including hip), or body wall
- •No sarcoma of the head and neck or intra-abdominal or retroperitoneal sarcoma
- •No desmoid tumor or dermatofibrosarcoma protuberans
- •No metastatic disease
- •No evidence of lung metastases
- •Maximum of 4 lung lesions no greater than 5 mm in diameter each on preoperative chest CT scan allowed OR
- •Lesion no greater than 1 cm allowed if stable for at least 1 year and fits criteria for granuloma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Zubrod 0-1
- •Life expectancy:
- •At least 2 years
- •Hematopoietic:
- •WBC at least 4,000/mm^3 OR
- •Absolute neutrophil count at least 1,800/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT no greater than 50 U/L
- •PT and PTT less than 1.25 times normal (not on warfarin)
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 50 mL/min
- •Cardiovascular:
- •No congestive heart failure or myocardial infarction within the past 6 months
- •No uncompensated coronary artery disease
- •No severe peripheral vascular disease
- •No peripheral vascular disease with diabetes mellitus
- •No deep venous or arterial thrombosis within the past 3 months
- •Fibrin split products less than 2 times normal
- •Fibrinogen greater than 200 mg/dL
- •No pulmonary embolism within the past 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No contraindications to surgery
- •No active uncontrolled bacterial, viral, or fungal infection
- •No other prior or concurrent malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
- •No other serious medical or psychiatric illness that would preclude informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy for soft tissue sarcoma
- •Chemotherapy:
- •No prior chemotherapy for soft tissue sarcoma
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- 另有 3 项未显示
排除标准
- 未提供
研究者
研究点 (451)
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