NCT00006361已完成2 期
A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: SU5416 may stop the growth of cancer cells by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced or recurrent cancer of the head and neck.
详细描述
OBJECTIVES:
- Determine the effect of SU5416 on survival and tumor response in patients with advanced or recurrent squamous cell carcinoma of the head and neck.
- Determine the safety and toxicity of SU5416 in these patients.
OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 1.4 years.
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 proven epidermoid/squamous cell carcinoma of the oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx; undifferentiated carcinoma of the nasopharynx (WHO type III); sinonasal undifferentiated carcinoma; or squamous cell carcinoma of unknown primary or the skin with initial presentation in the head and neck region
- •Advanced or recurrent disease that is incurable with surgery or radiotherapy
- •No more than 2 prior cytotoxic chemotherapy regimens for recurrent, persistent, or metastatic disease
- •Prior exposure to chemopreventive agents (e.g., tretinoin or other vitamin analogues) is not considered to be a prior cytotoxic chemotherapy exposure
- •At least 1 measurable indicator lesion
- •Bone metastases, elevated enzyme levels, or lesions on radionuclide scans are not acceptable as the sole parameters of measurable disease
- •No history of brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 3,000/mm3
- •Hemoglobin greater than 8 g/dL
- •Platelet count greater than 100,000/mm3
- •No history of coagulation disorder
- •Bilirubin normal
- •SGOT less than 2.5 times upper limit of normal
- •PT no greater than 14 seconds
- •aPTT no greater than 40 seconds
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No uncompensated coronary artery disease
- •No myocardial infarction or severe/unstable angina within the past 6 months
- •No severe peripheral vascular disease associated with diabetes mellitus
- •No deep venous or arterial thrombosis within the past 3 months
- •No unstable cardiac rhythm
- •No cerebrovascular accident within the past 6 months
- •No pulmonary embolism within the past 3 months
- •No history of allergic reaction to paclitaxel
- •No other active malignancy except:
- •Basal cell or squamous cell skin cancer
- •Carcinoma in situ of the cervix
- •Synchronous epidermoid/squamous cell carcinoma of the head and neck (oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active bacterial infection requiring antibiotics
- •No other concurrent medical condition that would increase risk
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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