Efficacy and safety of weekly nab-paclitaxel plus CBDCA in patients with CUP
- Conditions
- cancer of unknown primaryCUP, nab-Paclitaxel,CBDCA
- Registration Number
- JPRN-jRCTs051180084
- Lead Sponsor
- Yagi Toshinari
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 17
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method