Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
Eligibility criteria:
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 and currently be ineligible for cisplatin-based neoadjuvant chemotherapy due to any of the following:

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 radiation therapy) 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 participating organization
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 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 study physician immediately
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 the pre-study cystoscopy or radiologic imaging which identified the suspected bladder tumor 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 any immunotherapy received =< 6 months of study entry (with the exception of Bacillus Calmette-Guerin [BCG] treatment)
Any prior external beam radiation to the pelvis
A concurrent skin rash or skin condition requiring treatment with a prescription medication

The following medications may not be taken within 24 hours of the first dose of study agent 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 their last 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 for pain, is discouraged
Participants may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or clindamycin (topical agent for potential skin toxicity)
An underlying predisposition to rectal or gastrointestinal bleeding or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Females who are pregnant or lactating may not participate in this study; females of child-bearing potential must have a negative pregnancy test before starting study agent; patients who have had a bilateral oophorectomy, hysterectomy, or are greater than 1 year since their last menses are not considered to be of child-bearing potential