JPRN-jRCTs051180084已完成2 期
A phase2 study to evaluate the efficacy and safety of weekly nab-paclitaxel in combination with carboplatin in patients with cancer of unknown primary - Efficacy and safety of weekly nab-paclitaxel plus CBDCA in patients with CUP
Yagi Toshinari0 个研究点目标入组 17 人开始时间: 2019年2月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
研究概览
简要总结
This study was discontinued prematurely and the number of enrolled patients was a few. So, it does not lead to a certain conclusion. Judging from enrolled 17 cases, the RR and 50% of PFS were 41.2% and 28.9 weeks, respectively.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 years old =< 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Patients with histologically comfirmed metastatic malignant lesion, with no identifiable primary site by physical examination, imaging, and laboratory examination.
- •2)No indication for radical operation and radiotherapy.
- •3)Measurable disease according to RECIST(version1.1).
- •4)No prior chemotherapy for CUP.
- •5)ECOG scale: 0-1
- •6)Patient with enough feasibility for planned chemotherapy(hematological, liver, renal, cardiopulmonary function).
- •7)peripheral neuropathy <= Grade1
- •8)Patients who are expected to survive for more than 3 months.
- •9)Written informed consent.
排除标准
- •1)Pregnancy or breast feeding.
- •2)Patients unable to take nab-paclitaxel and CBDCA because of significant cardiovascular abnormalities, renal dysfunctions, hepatic insufficiency, uncontrolled diabetes, uncontrolled hypertension, bleeding tendency, active interstitial pneumonia,etc.
- •3)Known HIV active hepatitis B, active hepatitis C, and/or other known severe infections, including but not limited tuberculosis.
- •4)Ascites, pleural effusion, pericardial effusion, which require regular drainage.
- •5)Any other active malignancy unless free of disease for at least five years.
- •6)Known active brain metastasis.
- •7)Known hypersensitivity to any of platinum drugs, paclitaxel, and albumin containing drugs.
- •8)Known hypoadrealism which requires treatment
- •9)Specific clinicopathologic subgroups which have effective management.
- •a)Woman with isolated axillary lymph node metastasis.
- •b)Patients with CUP presenting as metastatic cervical or isolated inguinal lymphadenopathy(squamous cell carcinoma).
- •c)Men with features of the extra gonadal germ cell cancer syndrome.
- •d)Men with features of prostate cancer(adenocarcinoma, elevated level of PSA, and osteoblastic bone metastasis).
- •e)Neuroendcrine tumors.
研究者
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