Afatinib Dimaleate in Treating Patients with Advanced Refractory Urothelial Cancer

Active:	No
Cancer Type:	Bladder Cancer Unknown Primary Urethral Cancer	NCT ID:	NCT02122172
Trial Phases:	Phase II	Protocol IDs:	IRB13-0540 (primary) NCI-2014-00859 13-0540
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	University of Chicago Comprehensive Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT02122172

Summary

This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that has not responded to previous treatment (refractory). Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Objectives

PRIMARY OBJECTIVES:
I. To determine the 6-month progression free survival (PFS) rate of molecularly-selected metastatic urothelial cancer patients treated with afatinib dimaleate (afatinib) who have progressed despite prior platinum-based chemotherapy.

SECONDARY OBJECTIVES:
I. To determine the overall response rate (complete response [CR] + partial response [PR]), median progression free survival, and overall survival for the same treated population.
II. To examine the role of different ErBB alterations in determining afatinib activity in urothelial cancer.

TERTIARY OBJECTIVES:
I. To determine whether tumor EGFR and/or HER2 expression, or, alternatively, whether certain micro ribonucleic acid (RNA)s, influence 6-month PFS in patients treated with afatinib.

OUTLINE:
Patients receive afatinib dimaleate orally (PO) once daily (QD) on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28 days and then every 3 months for up to 3 years.

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