A Phase II Evaluation of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Progression-free Survival at 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 ovarian epithelial cancer or primary peritoneal cancer. 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
PRIMARY OBJECTIVES:
I. Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab.
II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug.
IV. Determine the frequency of clinical response in patients treated with this drug.
V. Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients.
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 ovarian epithelial or primary peritoneal carcinoma
- •Recurrent or persistent after initial standard surgery or chemotherapy
- •Incurable with standard surgery, chemotherapy, or radiotherapy
- •At least 1 unidimensionally measurable target lesion
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •Outside the area of prior radiotherapy
- •Accessible to guided core needle biopsy
- •Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease
- •May have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
- •Patients with only 1 prior platinum-based chemotherapy regimen must have an initial treatment-free interval of less than 12 months
- •Patients with an initial treatment-free interval of more than 12 months must have progressive disease after prior platinum-based chemotherapy regimen as second-line therapy
- •No tumors involving major blood vessels
- •No evidence of CNS disease (primary brain tumor or brain metastases) within the past 5 years
- •Ineligible for higher priority Gynecologic Oncology Group (GOG) protocols (i.e., active phase III GOG protocols for the same patient population)
- •Performance status - GOG 0-2 (patients who have received 1 prior regimen)
- •Performance status - GOG 0-1 (patients who have received 2 prior regimens)
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No known bleeding disorder or coagulopathy
- •No active bleeding
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •serum glutamate oxaloacetate transaminase (SGOT) ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •PT (INR) ≤ 1.5 (INR 2-3 if on stable dose of therapeutic warfarin or low molecular weight heparin)
- •Partial thromboplastin time (PTT) < 1.2 times control
- •Creatinine ≤ 1.5 times ULN
- •Creatinine clearance > 60 mL/min
- •No proteinuria, as indicated by 1 of the following:
- •Negative urine dipstick
- •Urine protein < 30 mg/dL
- •Urine protein < 1,000 mg on 24-hour urine collection
- •No clinically significant cardiovascular disease, including any of the following:
- •Uncontrolled hypertension
- •Myocardial infarction within the past 6 months
- •Unstable angina within the past 6 months
- •New York Heart Association class II-IV congestive heart failure
- •Serious cardiac arrhythmia requiring medication
- •Peripheral vascular disease ≥ grade 2
- •No stroke within the past 5 years
- •No pathologic condition that carries a high risk of bleeding
- •No significant traumatic injury within the past 28 days
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No uncontrolled seizures within the past 5 years
- •No neuropathy (motor and sensory) ≥ grade 2
- •No serious non-healing wound, ulcer, or bone fracture
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- •No active infection requiring parenteral antibiotics
- •No known claustrophobia that would preclude MRI tolerance
- •No ferromagnetic implants or pacers
- 另有 19 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 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Treatment (bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Progression-free Survival at 6 Months
时间窗: Every other cycle for 6 months.
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Tumor Response
时间窗: Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years.
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
时间窗: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, up to 5 years.
次要结局
- Overall Survival(From study entry to death or last contact, up to 5 years.)
- Duration of Progression-free Survival(Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years.)