A Phase II Evaluation of VEGF-Trap (AFLIBERCEPT, NSC #724770, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 134
- 主要终点
- Objective Tumor Response (RECIST 1.0)
研究概览
简要总结
This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer. VEGF Trap may stop the growth of endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing substances directly to endometrial cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. Assess the activity of VEGF Trap in patients with recurrent or persistent endometrial cancer, in terms of the frequency of patients who have progression-free survival for at least 6 months after initiating therapy or have objective tumor response.
II. Determine the toxicity of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the duration of progression-free survival and overall survival of 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 endometrial carcinoma, meeting both of the following criteria:
- •Recurrent or persistent disease
- •Refractory to curative therapy or established treatments
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Tumors within a previously irradiated field are designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy
- •Must have received one prior chemotherapeutic regimen for management of endometrial carcinoma (initial treatment may include high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment)
- •Not a candidate for a higher priority GOG protocol
- •No history or evidence of primary brain tumor or brain metastases
- •GOG performance status (PS) 0-2 (patients who received 1 prior regimen) OR GOG PS 0-1 (patients who received 2 prior regimens)
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Urine protein:creatinine ratio < 1.0 OR urine protein < 1.0 g by 24-hour urine collection
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •SGOT ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •PT/PTT/INR ≤ 1.5 times ULN
- •In-range INR (between 2 and 3) allowed if patient is on a stable dose of therapeutic warfarin
- •QTc < 500 msec
- •No evidence of serious ventricular arrhythmia
- •Ventricular tachycardia or ventricular fibrillation must be < 3 beats in a row
- •LVEF normal
- •Ejection fraction ≥ 50% (for patients who received prior anthracycline, including doxorubicin hydrochloride and/or doxorubicin hydrochloride liposome)
- •No clinically significant cardiovascular disease, including any of the following:
- •Uncontrolled hypertension, defined as systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg
- •Myocardial infarction or unstable angina within the past 6 months
- •NYHA class II-IV congestive heart failure
- •Serious cardiac arrhythmia requiring medication
- •Peripheral vascular disease ≥ grade 2
- •Cerebrovascular accident (i.e., CVA or stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
- •No HIV positivity
- •No neuropathy (sensory and motor) > grade 1
- •No active infection requiring antibiotics
- •No other invasive malignancies or any evidence of other cancer within the past 5 years except for nonmelanoma skin cancer
- •No serious nonhealing wound, ulcer, or bone fracture
- •No history of abdominal fistula or gastrointestinal perforation
- •No history or evidence of seizures not controlled with standard medical therapy
- •No intra-abdominal abscess within the past 28 days
- •No active bleeding or pathologic conditions that carry a high risk of bleeding (e.g., bleeding disorder, coagulopathy, or tumor involving major vessels)
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- •No significant traumatic injury within the past 28 days
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •Recovered from prior surgery
- •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
- •At least 1 week since prior hormonal therapy
- •Concurrent hormone replacement therapy allowed
- •At least 3 weeks since any other prior therapy, including immunologic agents
- 另有 16 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective Tumor Response (RECIST 1.0)
时间窗: Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; 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.
6 Month Progression-free Survival
时间窗: At 6 monthsEvery other cycle during treatment for the first 6 months.
Number of participants who survived progression-free for more than 6 months.
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
时间窗: Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Adverse events at least possibly related to the study agent.
次要结局
- Duration of Progression-free Survival(Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.)
- Duration of Overall Survival(Every 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.)