A Phase II Trial of Bevacizumab (rhuMAB VEGF) (NSC #704865) in the Treatment of Persistent and Recurrent Squamous Cell Carcinoma of the Cervix (Group A)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Progression-free Survival Greater Than 6 Months
研究概览
简要总结
This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
详细描述
OBJECTIVES:
I. Determine the cytostatic antitumor activity of bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with persistent or recurrent squamous cell carcinoma of the cervix.
II. Determine the nature and degree of toxicity of this drug in these patients. III. Estimate the distribution of PFS and overall survival for patients treated with this drug.
IV. Determine the frequency of clinical response (partial and complete) in patients treated with this drug.
V. Determine the role of age and initial performance status as prognostic factors in 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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed persistent or recurrent squamous cell carcinoma (SCC) of the cervix
- •Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix
- •Chemotherapy administered as a radio-sensitizer does not count as 1 regimen
- •Documented disease progression
- •At least 1 unidimensionally measurable lesion*
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •No tumor involving major blood vessels
- •No history or physical evidence of CNS disease, including primary or metastatic brain tumor
- •Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active GOG phase III protocol for the same patient population
- •Performance status - GOG 0-2 (if received 1 prior regimen)
- •Performance status - GOG 0-1 (if received 2 prior regimens)
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No known bleeding disorder or coagulopathy
- •No other active bleeding or pathologic condition that would confer a high risk of bleeding
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •SGOT ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •INR ≤ 1.5 (or 2-3 for patients on a stable dose of therapeutic warfarin or low molecular weight heparin)
- •PTT < 1.2 times control
- •Creatinine ≤ 1.5 times ULN
- •Creatinine clearance > 60 mL/min
- •No proteinuria
- •Urine protein < 1+ on dipstick or < 30 mg/dL
- •Urine protein < 1000 mg by 24-hour urine collection
- •No clinically significant cardiovascular disease
- •No uncontrolled hypertension
- •No myocardial infarction or unstable angina within the past 6 months
- •No New York Heart Association grade II-IV congestive heart failure
- •No serious cardiac arrhythmia requiring medication
- •No grade II or greater peripheral vascular disease
- •No history of stroke within the past 5 years
- •No greater than grade 1 sensory or motor neuropathy
- •No active infection requiring parenteral antibiotics
- •No serious nonhealing wound, ulcer, or bone fracture
- •No history or physical evidence of seizures not controlled with standard medical therapy
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
- •No significant traumatic injury within the past 4 weeks
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
- •No prior bevacizumab
- •At least 3 weeks since prior immunologic agents for SCC of the cervix
- •See Disease Characteristics
- •Recovered from prior chemotherapy
- •No prior non-cytotoxic chemotherapy for persistent or recurrent disease
- •At least 1 week since prior hormonal therapy for SCC of the cervix
- •Concurrent hormone replacement therapy allowed
- •See Disease Characteristics
- 另有 9 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
结局指标
主要结局
Progression-free Survival Greater Than 6 Months
时间窗: Every other 3-week treatment cycle for 6 months
Whether or not the patient survived progression-free for at least 6 months.
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
时间窗: Every cycle and 30 days after the end of treatment. (average 5 months)
The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.
次要结局
- Tumor Response(Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months))
- Overall Survival(From study entry to death or last contact, up to 5 years.)
- Duration of Progression-free Survival(Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years)
- Performance Status(Baseline)
- Age at Enrollment(Baseline)