Brief Title: Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• 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
• Ureter Cancer

ELIGIBILITY

Inclusion Criteria:
* Patients must have locally advanced or metastatic urothelial cancer that is not amenable to surgical treatment

- * Patients must have histologically or cytologically confirmed urothelial tract carcinoma; patients with urothelial carcinoma of the bladder, upper tract, or urethra are eligible

- * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan for the evaluation of measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1])

- * Patients must have evidence of disease progression prior to enrollment

- * All patients must have received a prior platinum-based chemotherapy regimen for treatment of urothelial cancer and must now be considered refractory to platinum-based chemotherapy; patients may have received the platinum-containing regimen either in the peri-operative or metastatic setting

- * Patients may have received up to one line of prior systemic chemotherapy for recurrent/metastatic disease; if a platinum-based regimen was received both in the peri-operative setting and again in the metastatic setting, this will be considered 1 line of chemotherapy

- * Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- * Absolute neutrophil count >= 1,000/mcL

- * Platelets >= 100,000/mcL

- * Hemoglobin >= 8.5g/dL

- * Total bilirubin =< 1.5 institutional upper limit of normal (IULN) - * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X IULN - * Calculated creatinine clearance >= 30 mL/min by the modified Cockcroft and Gault Formula OR glomerular filtration rate >= 30 mL/min/body surface area (BSA) by Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

- * Women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

- * Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients may not be receiving any other investigational agents

- * Patients with untreated known brain metastases, or treated brain metastases that are clinically unstable

- * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements

- * Women known to be pregnant

- * Women who are breastfeeding and who are unwilling to stop breastfeeding prior to study entry

- * Patients with known prior human immunodeficiency virus (HIV)-positive status on combination antiretroviral therapy are ineligible; known prior HIV-positive patients with CD4+ =< 500/mm^3 are ineligible (HIV testing is not required as part of this study) - * Pre-existing interstitial lung disease - * Inability to take oral medications - * Prior therapy with afatinib

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Peter O'Donnell

Role: Principal Investigator

Affiliation: University of Chicago

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION