Afatinib in Advanced Refractory Urothelial Cancer
Distal Urethral Cancer
Proximal Urethral Cancer
Recurrent Bladder Cancer
Recurrent Urethral Cancer
Stage III Bladder Cancer
Stage III Urethral Cancer
Stage IV Bladder Cancer
Stage IV Urethral Cancer
Drug: afatinib dimaleate
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer|
- Progression-free survival (PFS) [ Time Frame: 3 months ]Estimated using the Kaplan-Meier method.
- Overall response rate (CR + PR) [ Time Frame: Up to 3 years ]
- Median progression-free survival (PFS ) time [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
- Overall survival [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
- EGFR expression status [ Time Frame: Baseline ]Relationship to 3-month PFS will be determined.
- HER2 expression status [ Time Frame: Baseline ]Relationship to 3-month PFS will be determined.
- Presence of tumor micro ribonucleic acids (RNAs) like miR-200 [ Time Frame: Baseline ]Relationship to 3-month PFS will be determined.
- Epithelial to mesenchymal transition states [ Time Frame: Up to 3 years ]
- Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 28 days after last administration of trial drugs ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (afatinib)
Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: afatinib dimaleate
Other Names:Other: laboratory biomarker analysis
I. To determine the 3-month progression free survival (PFS) rate in metastatic urothelial cancer patients receiving afatinib (afatinib dimaleate) who have progressed despite prior platinum-based chemotherapy.
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 determine whether tumor epidermal growth factor receptor (EGFR) and/or HER2 overexpression influences 3-month PFS in patients treated with afatinib.
Patients receive afatinib dimaleate orally (PO) once daily (QD) on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02122172
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|NorthShore University Health System|
|Evanston, Illinois, United States, 60201|
|Principal Investigator:||Peter O'Donnell||University of Chicago|