afatinib in advanced refractory urothelial cancer

Conditions: 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

Summary: this phase ii trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy. afatinib dimaleate may turn off the function of the epidermal growth factor (egf) and human epidermal growth factor receptor 2 (her2) receptors, which may slow the growth of cancer cells or cause some of the cells to die.

primary objectives: 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. 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 determine whether tumor epidermal growth factor receptor (egfr) and/or her2 overexpression influences 3-month pfs in patients treated with afatinib. outline: 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.

Eligibility criteria:
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