Trial of Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma
The primary objective of this study is to determine in subjects with metastatic measurable bladder cancer (or urothelial cancers originating elsewhere in the genitourinary tract) who have progressed on 1 prior chemotherapeutic regimen the objective response rate to treatment with amrubicin. The secondary objectives will be to evaluate progression-free survival, survival at 1 year, and the safety of amrubicin as second-line therapy in patients with metastatic urothelial carcinoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-Center Phase 2 Trial of Single-Agent Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma|
- Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Tumor measurements via CT chest, abdomen, and pelvis for restaging after every 2 cycles
- Progression-free survival [ Time Frame: Every 3 months post Amrubicin administration ] [ Designated as safety issue: No ]After the last dose of Amrubicin, patients will have follow-up every 3 months with a repeat CT scan of the chest, abdomen, and pelvis until the time of disease progression is documented.
- Survival at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Safety as measured by the frequency and type of adverse events as per the Common Terminology for Adverse Events (CTCAE) version 4.0. [ Time Frame: Day 1 of each treatment cycle; and 21 days after the last dose of amrubicin ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
35 mg/m2/day intravenously
Patients will receive 35 mg/m2/day of amrubicin intravenously for 3 consecutive days as the initial dose starting on Day 1 of a 21-day cycle for up to 6 cycles
Multiple small phase II trials exploring a variety of agents as second-line therapy for metastatic urothelial carcinoma have been performed. Overall, the most active of these agents have shown response rates of approximately 10-20% . Currently, there are no FDA approved agents for the second-line treatment of metastatic urothelial carcinoma.
The current study will explore the safety and activity of the novel anthracycline, amrubicin, as second-line chemotherapy in patients with advanced urothelial carcinoma.
The primary objective will be to evaluate the activity (as determined by objective response rate) of amrubicin as second-line chemotherapy in patients with metastatic urothelial carcinoma. The secondary objectives will be to evaluate progression-free survival, survival at 1 year, and the safety of amrubicin as second-line therapy in patients with metastatic urothelial carcinoma.
Subjects will receive amrubicin IV daily x 3 days, every 21-days, with prophylactic granulocyte colony stimulating factor. This 21-day time period is referred to as a cycle. Subjects will undergo repeat computed tomography (CT) scans after every 2 cycles. In the absence of progressive cancer, or prohibitive side effects, subjects will receive up to 6 cycles of treatment with amrubicin.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331824
|United States, Arizona|
|Banner MD Anderson Cancer Center|
|Gilbert, Arizona, United States, 85234|
|United States, Indiana|
|Indiana University Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Matthew D Galsky, MD||Mount Sinai School of Medicine|