NCT02884648进行中（未招募）2 期
A Phase II Investigation of Bevacizumab for the Treatment of Second-Look Positive Epithelial Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab
研究概览
简要总结
The goal of this clinical research study is to learn if Avastin (bevacizumab) can help to control ovarian, fallopian, or primary peritoneal cancer that has been found during second-look surgery.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in the study, you will receive bevacizumab by vein over about 30 minutes on Day 1 of every 21-day study cycle.
Study Visits:
Your first study visit will be about 5-7 weeks after your second-look surgery so that you have time to recover. The study doctor will tell you when you will start having study visits.
During all cycles:
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
- •1. Signed written Informed Consent (in participant's preferred language or short form, per SOP04).
- •2. Age\>/= 18 years of age or older.
- •3. Histologically confirmed Stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancers.
- •4. Have received standard of care frontline surgical and chemotherapy treatment (at least six cycles of platinum and taxane therapy). Patients who received neoadjuvant therapy are included.
- •5. Have undergone a second-look surgery by an MD Anderson Gynecologic Oncology faculty after having achieved a complete clinical response to frontline surgery and adjuvant chemotherapy as evidenced by (a) normal physical exam, (b) normal CT or positron emission computed tomography (PET)-CT of abdomen and pelvis or other equivalent imaging, and (c) normalization of CA125 (\<35 U/mL).
- •6. Histologically confirmed residual ovarian cancer at time of second-look surgery. Patients with cytological evidence of malignant cells in washings obtained as part of the second look procedure are eligible even if biopsies are negative.
- •7. Be willing to allow use of archival tissue from second-look surgery and primary surgery or biopsy for use in this study.
- •8. Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale at the time of screening.
- •9. Have adequate organ function as determined by the following laboratory values: a) absolute neutrophil count (ANC) \>/= 1,000 /mcL; b) Platelets \>/= 100,000/mcL; (c) Hgb \>/= 8 g/dL; (d) Creatinine Clearance \>/= 40 mL/min (measured or calculated per local practice); (e) Total Bilirubin \ 1 year.
排除标准
- •Uncontrolled hypertension as defined by SBP>150 or DBP>90 on at least two separate occasions documented in the medical record. Patients would be eligible if blood pressure is controlled with appropriate anti-hypertensive therapy. Rescreening after this therapy has been instituted is allowed.
- •Histology showing mucinous or low-grade epithelial ovarian carcinoma.
- •Documented germline or somatic BRCA mutations and/or HRD positivity.
- •Planned use of maintenance or consolidative therapy.
- •History of known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the Study.
- •History of arterial thrombosis. Patients with history of DVT are eligible as long as they have received or are receiving appropriate anticoagulation therapy.
- •History of gastrointestinal or urinary fistulae, non-healed or chronic wound, or other conditions that, in the investigator's view, would contraindicate or significantly increase the risks of bevacizumab therapy.
- •History of known hemoptysis, gastrointestinal or intracerebral hemorrhage.
- •Patient that is not able to understand or to comply with the study instructions and requirements, or has a history of non-compliance to the medical regimen.
- •Concurrent or planned use of any other anti-cancer systemic chemotherapy, biological therapy (including hormonal or immune therapy), radiation therapy, or live cancer vaccines.
- •Prior use of bevacizumab or a biosimilar in the frontline treatment setting.
研究组 & 干预措施
Bevacizumab
Experimental
Participants receive Bevacizumab by vein on Day 1 of every 21-day study cycle, for as long as study doctor thinks it is in participant's best interest.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab
时间窗: 63 days
PFS defined as the interval between the first dose of Bevacizumab and radiographically demonstrated progression by RECIST criteria.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
A Study of Bevacizumab to Prevent Malignant AscitesMalignant AscitesNCT00908219Baylor College of Medicine
已完成
2 期
Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell CarcinomaKidney CancerRenal Cell CarcinomaNCT00113217M.D. Anderson Cancer Center52
已完成
2 期
Bevacizumab and Lapatinib in Children With Recurrent or Refractory EpendymomaBrain CancerPediatric CancersNCT00883688M.D. Anderson Cancer Center24
已完成
1 期
A Pilot Study of Bevacizumab for Neoplastic MeningitisNeoplastic MeningitisNCT00924820M.D. Anderson Cancer Center20
撤回
不适用
Pilot Study of Bevacizumab (Avastin) in Patients With Septic ShockSeptic ShockNCT01063010Beth Israel Deaconess Medical Center