Phase II pilot study of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy.
- Conditions
- urothelial cancer
- Registration Number
- JPRN-UMIN000015260
- Lead Sponsor
- Department of Urology, Saitama Medical Center, Saitama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Not provided
Patients 1) have a treatment history of paclitaxel treatment 2) have an allergy to albumin 3) have a heavy infection 4) have severe complications: interstitial pulmonary fibrosis, gastrointestinal hemorrhage, ileus, uncontrollable diabetes mellitus, cardiovascular disease, etc. 5) have an uncontrollable pleural, ascites or pericardial effusion. 6) have an active cancer except urothelial cancer: cancer free duration < 5 years. 7) have a brain metastasis with symptoms requiring steroids or anti-seisure medications 8) have a history of salvage radiation to primary organ or lymph node metastasis within two weeks. 9) do not meet the inclusion criteria due to mental disorders or neurological symptoms 10) have no intention to birth control 11) disqualified by a doctor in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method