A Phase II Study of VEGF-Trap in Recurrent or Metastatic Gynecologic Soft-Tissue Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 16
- 主要终点
- Objective Response Rate, Evaluated According to the RECIST Criteria
研究概览
简要总结
This phase II trial is studying how well ziv-aflibercept works in treating patients with locally advanced, unresectable or metastatic gynecologic soft tissue sarcoma. Ziv-aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. To assess the objective response of recurrent or metastatic gynecologic soft-tissue sarcomas to VEGF-Trap (ziv-aflibercept).
II. To assess the incidence of disease stabilization, as measured by 6-month progression-free survival, in patients with recurrent or metastatic gynecologic soft-tissue sarcomas treated with VEGF-Trap.
SECONDARY OBJECTIVES:
I. To assess time-to-progression and overall survival in patients with recurrent or metastatic gynecologic soft-tissue sarcoma treated with VEGF-Trap.
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/cytologically confirmed soft tissue sarcoma of gynecologic tract including 1 of the following subtypes: uterine leiomyosarcoma, malignant mixed mullerian tumor/carcinosarcoma, disease originating in ovary/fallopian tube allowed
- •Locally advanced/unresectable/metastatic disease
- •Previously treated disease must have radiographic/clinical evidence of PD
- •Measurable disease-at least 1 lesion in at least 1 dimension (longest diameter) as >=20mm with conventional techniques or as >=10mm with spiral CT scan
- •Indicator lesions may not have been previously treated with surgery/radiotherapy/radiofrequency ablation unless PD has been confirmed
- •ECOG PS 0-2 OR Karnofsky PS 60-100%
- •Life expectancy>=3 months
- •WBC>=3,000/mm^3
- •Absolute neutrophil count>=1,500/mm^3
- •Platelet count>=75,000/mm^3
- •Bilirubin=<1.5xULN
- •AST and ALT=<3xULN
- •INR=<1.5 (unless on warfarin)
- •Creatinine=<1.5xULN OR creatinine clearance>=60 mL/min
- •Urine protein<1+ by dipstick OR 24-hour urine protein<500 mg OR urine protein:creatinine ratio<1
- •Not pregnant/nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥6 months after treatment - No other active malignancy within past 5 years except adequately treated cervical carcinoma in situ/nonmelanoma skin cancer
- •No known hypersensitivity to Chinese hamster ovary cell products/other recombinant human antibodies
- •No history of allergic reactions attributed to compounds of similar chemical/biological composition to study agents
- •No serious/nonhealing wound/ulcer/bone fracture
- •No abdominal fistula/gastrointestinal perforation/bowel obstruction/intraabdominal abscess within past 28 days
- •No significant traumatic injuries within past 28 days
- •No evidence of bleeding diathesis/coagulopathy
- •No uncontrolled intercurrent illness including but not limited to: Ongoing/active infection, psychiatric illness or social situations that would preclude study compliance
- •<=2 prior cytotoxic chemotherapy regimen for recurrent, locally advanced or metastatic disease
- •Recovered from prior therapy
- •No prior antiangiogenic agent
排除标准
- •< 4weeks since prior chemotherapy (<6 weeks for nitrosoureas/carmustine/mitomycin C), prior investigational treatment, radiotherapy and major surgery/open biopsy
- •1 week since prior core biopsy
- •1 month since prior thrombolytic agents
- •Concurrent full-dose anticoagulants with INR>1.5 allowed if: In-range INR (usually between 2-3) on stable dose of oral anticoagulant or low molecular weight heparin,
- •OR; For patients on warfarin, the upper target for INR is ≤3 No active bleeding/pathological condition that carries a high risk of bleeding (e.g. tumor invading major vessels/known varices)
- •No evidence of CNS disease including primary brain tumor/brain metastasis
- •No other concurrent investigational agents - No concurrent major surgery
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •Clinically significant cardiovascular disease including:
- •Cerebrovascular accident within past 6 months,
- •Uncontrolled hypertension defined as BP>150/100mmHg OR systolic BP>180mmHg if diastolic BP<90 mmHg, on ≥2 repeated determinations on separate days within past 3 months,
- •OR; Antihypertensive medications allowed as long as dose and number of antihypertensive medications have not increased within past 2 weeks, Myocardial infarction, coronary artery bypass graft, or unstable angina within past 6 months, OR;
- •OR; NYHA class III-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris within past 6 months, Clinically significant peripheral vascular disease within past 6 months
- •OR; pulmonary embolism, deep vein thrombosis, or other thromboembolic event within past 6 months
研究组 & 干预措施
Treatment (ziv-aflibercept)
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: ziv-aflibercept (Drug)
结局指标
主要结局
Objective Response Rate, Evaluated According to the RECIST Criteria
时间窗: Up to 3 years
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)
时间窗: 6 months
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)
时间窗: 6 months
次要结局
- Survival (Leiomyosarcoma Group)(Up to 3 years)
- Survival (Carcinosarcoma Group)(Up to 3 years)