Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery
Condition: Bladder Carcinoma; Recurrent Bladder Carcinoma
MeSH terms: Carcinoma; Urinary Bladder Neoplasms
Intervention: Erlotinib Hydrochloride; Laboratory Biomarker Analysis; Pharmacological Study; Placebo; Quality-of-Life Assessment; Therapeutic Conventional Surgery
Intervention description: Given PO; Correlative studies; Correlative studies; Given PO; Ancillary studies; Undergo TURBT or cystectomy
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well erlotinib hydrochloride works in treating
      patients with bladder cancer undergoing surgery. Erlotinib hydrochloride may stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth.
    

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