A phase2 study to evaluate the efficacy and safety of weekly nab-paclitaxel in combination with carboplatin in patients with cancer of unknown primary
- Conditions
- cancer of unknown primary (CUP)
- Registration Number
- JPRN-UMIN000012204
- Lead Sponsor
- Osaka International Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 28
Not provided
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)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 response rate
- Secondary Outcome Measures
Name Time Method progression free survival, overall survival, adverse event