NCT00026260已完成2 期
A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
研究概览
简要总结
RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer.
详细描述
OBJECTIVES:
- Determine the antitumor cytostatic activity of SU5416, in terms of 6-month progression-free survival and time to progression, in patients with persistent or recurrent cervical squamous cell carcinoma.
- Determine the nature and degree of toxicity of this drug in these patients.
- Correlate surrogate endpoint molecular and imaging markers with clinical outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 1 hour on days 1 and 4. Treatment repeats weekly 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.
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 confirmed cervical squamous cell carcinoma
- •Persistent or recurrent disease with documented progression
- •No nonsquamous cell cervical malignancies, including adenosquamous carcinoma
- •At least 1 measurable 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
- •Failed prior local therapeutic measures
- •Ineligible for higher priority GOG protocol (e.g., any active GOG phase III protocol for the same patient population)
- •Tumor must be accessible for biopsy using direct- or guided-needle technique
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count at least lower limit of normal
- •Absolute neutrophil count at least 1,500/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 OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No uncompensated coronary artery disease on electrocardiogram or physical examination
- •No myocardial infarction within the past 6 months
- •No severe/unstable angina within the past 6 months
- •No severe peripheral vascular disease
- •No deep vein or arterial thrombosis within the past 3 months
- •No pulmonary embolism within the past 3 months
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Must have central venous access
- •No uncontrolled diabetes mellitus
- •No prior allergic reaction to paclitaxel
- •No active infection requiring antibiotics
- •No peripheral neuropathy greater than grade 1
- •No contraindications to low-dose (1 mg/day) warfarin or low-molecular weight heparin prophylaxis
- •No claustrophobia that would preclude MRI studies
- •No ferromagnetic implants or pacers
- •No other invasive malignancy within the past 5 years except non-melanoma skin cancer
- •No other concurrent circumstances that would preclude study completion
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Biologic therapy:
- •No prior antiangiogenesis agents, including SU5416
- •At least 3 weeks since prior biologic or immunologic agents directed at malignancy
- •Chemotherapy:
- •No more than 1 prior chemotherapy regimen, including single or combination cytotoxic drug therapy (radiosensitizers do not count as prior regimen)
- •At least 3 weeks since prior chemotherapy directed at malignancy and recovered
- 另有 8 项未显示
排除标准
- 未提供
研究者
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