Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer
Condition: Recurrent Bladder Urothelial Carcinoma; Recurrent Renal Pelvis Urothelial Carcinoma; Recurrent Ureter Urothelial Carcinoma; Recurrent Urethral Urothelial Carcinoma; Stage 0a Bladder Cancer AJCC v8; Stage 0a Renal Pelvis Cancer AJCC v8; Stage 0a Ureter Cancer AJCC v8; Stage 0a Urethral Cancer AJCC v8; Stage 0is Bladder Cancer AJCC v8; Stage 0is Renal Pelvis Cancer AJCC v8; Stage 0is Ureter Cancer AJCC v8; Stage 0is Urethral Cancer AJCC v8; Stage II Bladder Cancer AJCC v8; Stage II Renal Pelvis Cancer AJCC v8; Stage II Ureter Cancer AJCC v8; Stage II Urethral Cancer AJCC v8; Stage III Renal Pelvis Cancer AJCC v8; Stage III Ureter Cancer AJCC v8; Stage III Urethral Cancer AJCC v8; Stage IIIA Bladder Cancer AJCC v8
MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Urethral Neoplasms; Ureteral Neoplasms; Pelvic Neoplasms; Kidney Neoplasms; Recurrence
Intervention: Erlotinib Hydrochloride
Intervention description: Given PO
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well erlotinib hydrochloride works in Treating participants
      with muscle invasive urothelial cancer or urothelial cancer that has come back. Drugs used in
      chemotherapy, such as erlotinib hydrochloride, work in different ways to stop the growth of
      tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them
      from spreading.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologic proof of urothelial cancer. This includes bladder
             cancer, in addition to other tumors of the urothelial lining including renal pelvis,
             ureteral, and urethral cancer. This group may include any patient requiring
             cystectomy, including patients with recurrent or extensive superficial disease
             (cTa-T1N0M0), CIS (carcinoma in situ), or muscle invasive disease (cT2-3aN0M0), whose
             tumor could not be completely removed at transurethral resection

          -  Patients with the following high-risk features: Micropapillary features (more than
             focal on pathology); Small cell carcinoma; 3-dimensional (D) mass on exam under
             anesthesia (EUA); Lymphovascular invasion; Hydronephrosis (unless in the opinion of
             the treating physician, this is not due to tumor); High grade (grade 3) tumors of the
             ureter, renal pelvis, or urethra, or tumors in these areas with radiographic
             abnormality large enough to recognize as an abnormal mass by computed tomography (CT)
             or magnetic resonance imaging (MRI) imaging; Direct invasion of the prostatic stroma
             or the vaginal wall (ie: cT4a disease) should be offered neoadjuvant cytoreductive
             chemotherapy (ie: cisplatin-based). Patients refusing or who are not considered
             candidates for cytoreductive chemotherapy may be considered eligible. Dr.
             Siefker-Radtke will be the final arbiter in determining eligibility for the trial

          -  Please note that the presence of variant histologic subtypes is acceptable, except in
             the case for small cell variant which is traditionally treated with cytoreductive
             chemotherapy. Patients with small cell who refuse recommended cytoreductive
             chemotherapy may still be considered eligible

          -  Patients must have an evaluation in the department of urology, and be deemed an
             acceptable surgical candidate

          -  Patients must NOT have clinical evidence of metastatic disease by either CT or MRI of
             the abdomen and pelvis, and chest x-ray. In the absence of a bone scan, patients
             should be free of bone pain and have an alkaline phosphatase < 1.5 x upper limit of
             normal (ULN) of the upper limit of normal, or a normal bone fraction of alkaline
             phosphatase. If these features are present, patients should have a bone scan and this
             should be interpreted as showing no evidence of metastatic disease in order to be
             eligible

          -  Patients, 18 years and older, must either be not of child bearing potential or have a
             negative pregnancy test within 2 weeks of treatment. Patients are considered not of
             child bearing potential if they are surgically sterile (they have undergone a
             hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
             postmenopausal

          -  Absolute neutrophil count (ANC) >= 1,000/ul

          -  Platelets >= 75,000/microliters

          -  Creatinine =< 2.0 x institutional upper limit of normal (ULN), or a creatinine
             clearance of > 30 ml/min as calculated by Cockroft-Gault or by 24-hour urine
             collection

          -  Bilirubin =< 2.5 x ULN

          -  Aspartate aminotransferase (AST) =< 5.0 x ULN

          -  Zubrod performance status (PS) =< 2

          -  Patients with second malignancies are eligible provided that the expected outcome from
             the second cancer is such that this will not interfere in the delivery of this
             therapy, or in doing cystectomy, and provided that the expectation of survival from
             any prior malignancy is reliably > 4 years

        Exclusion Criteria:

          -  Acute hepatitis or known human immunodeficiency virus (HIV)

          -  Active or uncontrolled infection

          -  Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
             unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
             congestive heart failure, and cardiomyopathy with decreased ejection fraction =< 40%

          -  Prior therapy specifically and directly targeting the EGFR pathway

          -  Patients with interstitial lung disease

          -  Any concurrent chemotherapy not indicated in the study protocol or any other
             investigational agent(s)

          -  Patients with metastatic or surgically unresectable disease are not eligible for this
             study. In addition, patients who do not agree to surgery are not eligible for this
             trial

          -  Patients who have received prior systemic chemotherapy or radiation therapy for
             urothelial cancer are not eligible. Any prior intravesical chemotherapy is allowed