Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery

Inclusion Criteria:

• Participants must have a confirmed or suspected invasive or non-invasive bladder tumor (initial or recurrent) discovered on cystoscopy or radiologic imaging performed within 120 days of randomization

• Patients with muscle invasive bladder cancer (MIBC) must have never received andcurrently be ineligible for cisplatin-based neoadjuvant chemotherapy due to any of thefollowing:

• Calculated creatinine clearance of < 60 ml/min

• Karnofsky performance status (KPS) < 80

• Solitary kidney or

• Patient refusal to undergo neoadjuvant chemotherapy

• The participant may have prior treatment for bladder tumor (excluding radiationtherapy) provided that treatment:

• Was completed greater than 30 days prior to the first dose of study agent

• Participants must be a candidate for a trans-urethral resection of the bladder tumor (TURBT), cystectomy (partial or radical) or cystoscopy with biopsy at a participatingorganization

• Karnofsky >= 60%

• White blood cells (WBC) >= 3000/mm^3

• Platelets >= 100,000mm^3

• Hemoglobin > 10 g/dL

• Alkaline phosphatase =< 1.5 x upper limit of normal

• Bilirubin =< 1.5 x upper limit of normal

• Aspartate aminotransferase (AST) =< 1.5 x upper limit of normal

• Alanine aminotransferase (ALT) =< 1.5 x upper limit of normal

• Bilirubin for Gilbert's =< 3.0 mg/dl

• A calculated creatinine clearance (Cockcroft Gault) of >= 30 ml/min

• Sodium >= 130 mg/dl and =< upper limit of normal

• Potassium >= 3.0 mg/dl and =< upper limit of normal

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and forthe duration of study participation; should a woman become pregnant or suspect she ispregnant while participating in this study, she should inform her study physicianimmediately

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Any treatment for the bladder tumor other than intravesical therapy between thepre-study cystoscopy or radiologic imaging which identified the suspected bladdertumor and the scheduled surgical removal or cystoscopy-guided biopsy of that tumor

• Any chemotherapy and/or radiation therapy received =< 3 months of study entry and anyimmunotherapy received =< 6 months of study entry (with the exception of BacillusCalmette-Guerin [BCG] treatment)

• Any prior external beam radiation to the pelvis

• A concurrent skin rash or skin condition requiring treatment with a prescriptionmedication

• The following medications may not be taken within 24 hours of the first dose of studyagent or at any time while a participant is taking study agent

• Coumadin

• Strong CYP3A4 inhibitors including ketoconazole, atazanavir, boceprevir,ceritinib, clarithromycin, cobicistat, darunavir, dasabuvir, idelalisib,indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ombitasvir,paritaprevir, posaconazole, ritonavir, saquinavir, telithromycin, troleandomycin,voriconazole, and grapefruit or grapefruit juice

• CYP3A4 inducers including rifampicin, rifabutin, rifapentine, phenytoin,carbamazepine, phenobarbital, primidone, enzalutamide, fosphenytoin, lumacaftor,mitotane, and St. John's wort

• Agents which decrease gastric acid are allowed but should be avoided if possible

• Participants may resume inhibitors or inducers of CYP3A4 > 14 days after theirlast dose of study agent

• Participants requiring daily use of non-steroidal anti-inflammatory drugs (NSAIDs),with the exception of =< 81 mg aspirin per day; during study participation,acetaminophen is preferred for treatment of pain; the use of NSAIDs, as needed forpain, is discouraged

• Participants may not be receiving any other investigational agents

• History of allergic reactions attributed to compounds of similar chemical or biologiccomposition to erlotinib or clindamycin (topical agent for potential skin toxicity)

• An underlying predisposition to rectal or gastrointestinal bleeding or uncontrolledintercurrent illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, orpsychiatric illness/social situations that would limit compliance with studyrequirements

• Females who are pregnant or lactating may not participate in this study; females ofchild-bearing potential must have a negative pregnancy test before starting studyagent; patients who have had a bilateral oophorectomy, hysterectomy, or are greaterthan 1 year since their last menses are not considered to be of child-bearingpotential