ACTRN12611000801910已完成2 期
A Phase II study to evaluate the safety and potential palliative benefit of intraperitoneal bevacizumab in patients with symptomatic ascites due to advanced chemotherapy resistant gynaecological cancers: REZOLVE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1. Patients with symptomatic, cytologically confirmed malignant ascites;
- •a. Where ascites is due to histologically confirmed platinum resistant or refractory recurrent epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer
- •b. Who have required at least one therapeutic ascitic drainage in the 4 weeks prior to study registration
- •c. Who are either not receiving or not planned to receive additional systemic chemotherapy,
- •2. Age >18 years
- •3. ECOG 0-3
- •4. Estimated survival of 12 weeks or more
- •5. Study treatment both planned and able to start within 14 days of registration.
- •6. Willing and able to comply with all study requirements, including treatment timing and/or nature of required assessments
- •7. Signed, written informed consent
排除标准
- •1. At high risk of bowel perforation, including but not limited to any one or more of the following;
- •a. History of previous bowel obstruction prior to study entry
- •b. CT scans that suggest involvement of bowel by tumour
- •c. Symptoms to suggest impending bowel obstruction
- •d. Prior whole abdominal radiotherapy
- •2. Active or non-healing intra-abdominal fistulae or history of fistulae within previous 60 days
- •3. Major surgery within the preceding 6 weeks
- •4. Pulmonary emboli or deep vein thrombosis unless on anticoagulation and no thrombotic episode in the preceding 6 weeks.
- •5. Known bleeding diathesis, or history of active bleeding including known gastric ulceration within 60 days
- •6. Uncontrolled hypertension, or unstable cardiac disease
- •7. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •8. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
- •9. Pregnancy, lactation, or inadequate contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.
- •10. Previous episode of ascites due to non-malignant causes, for example hepatic failure, portal venous obstruction
- •11. Known hypersensitivity to or serious reaction resulting from any components of bevacizumab, Chinese hamster ovary cell products or other recombinant human or humanised antibodies,
- •12. Have received anti-VEGF therapy within the last 3 months
研究者
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