Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma

Inclusion criteria

• ✓. Histologically confirmed diagnosis of urothelial carcinoma (UC) that is either metastatic (any N+ M1) or locally advanced and unresectable (T4bN0). A component of urothelial (transitional cell) carcinoma is required.
• ✓. Two groups of patients are eligible:
• ✓. Poor candidates for cisplatin-based chemotherapy based on the presence of ≥ 1 the following:
• ✓. Poor prognosis and defined as cisplatin-incurable due to the presence of metastasis to at least one visceral site (these patients are not required to have any of the cisplatin-ineligibility criteria).
• ✓. Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• ✓. Patients with brain metastases are allowed if treatment was completed at least 4 weeks prior to study treatment, neurologic symptoms are minimal and stable during the preceding 4 weeks, and maintenance dexamethasone is not required.
• ✓. Adequate hematologic, liver and kidney function.
• ✓. Willingness and ability to comply with study requirements and give written informed consent.

Exclusion criteria