Last updated on March 2018

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

Brief description of study

The purpose of this trial is to determine the benefit of the combination of nab-paclitaxel plus gemcitabine given for 6 cycles, followed by maintenance nab-paclitaxel alone, in patients with cisplatin-ineligible or cisplatin-incurable advanced urothelial carcinoma (UC).

Detailed Study Description

This open-label, non-randomized phase II trial evaluates the efficacy and toxicity of first-line treatment with a combination of gemcitabine and nab-paclitaxel, followed by maintenance therapy with nab-paclitaxel alone in patients with metastatic or locally advanced unresectable urothelial cancer. Two groups of patients are eligible: (1) patients who are poor candidates for treatment with cisplatin, and (2) patients with visceral metastases who are incurable and unlikely to derive long-term benefit from treatment with cisplatin-based regimens. Eligible patients will receive a minimum of 3 cycles and up to 6 cycles of treatment with the gemcitabine/nab-paclitaxel combination. Patients having an objective response or stable disease will continue maintenance treatment with single-agent nab-paclitaxel until disease progression, intolerable toxicity, or patient decision to discontinue treatment. Up to 55 patients are planned for enrollment.

Clinical Study Identifier: NCT02887248

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Florida Cancer Specialists - South
Fort Myers, FL United States

Florida Cancer Specialists-North
Saint Petersburg, FL United States

Florida Cancer Specialists-East
West Palm Beach, FL United States

Tennessee Oncology
Nashville, TN United States

Center for Cancer and Blood Disorders
Fort Worth, TX United States