Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
Condition: Distal Urethral Cancer; Proximal Urethral Cancer; Squamous Cell Carcinoma of the Bladder; Stage II Bladder Cancer; Stage III Bladder Cancer; Urethral Cancer Associated With Invasive Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms
Intervention: gemcitabine hydrochloride; cisplatin; therapeutic conventional surgery; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Undergo radical cystectomy; Correlative studies
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find out what effects, good and/or bad, dose-dense
      (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given
      before surgery have on patients and their muscle invasive bladder cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed urothelial carcinoma of the bladder or
             urethra; patients with urothelial carcinoma of the prostatic urethra only may be
             included at primary investigator (PI) discretion; T-stage must be T2 to T4a; patients
             with radiographic N0 disease or N1 disease are eligible for the study; patients must
             not have radiographic evidence of metastatic disease; mixed histologies which are
             predominantly urothelial, such as with squamous or micropapillary differentiation, are
             allowed so long as there is no component of small cell histology; histology must be
             confirmed by a pathologist at an institution involved in this study

          -  Patients must be candidates for radical cystectomy with the goal of cure

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin =< institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase [SGPT]) =<
             2.5 X institutional ULN

          -  Patients must have adequate renal function defined as creatinine clearance >= 50
             mL/min; for eligibility, creatinine clearance may be either calculated using the
             Cockcroft-Gault formula or measured with 24 hour urine collection; note that 24 hour
             urine collection is required at baseline, but does not have to be used for eligibility
             if calculated clearance by Cockcroft-Gault is preferred; nephrostomy or ureteral stent
             placement in order to achieve adequate creatinine clearance is allowed

          -  Women of child-bearing potential (WOCBP) and men with a female partner who is a WOCBP
             must agree to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) starting prior to beginning treatment and continuing until at least 3
             months after last dose of chemotherapy and surgery; should a woman become pregnant or
             suspect she is pregnant while participating in this study or if a female partner of a
             man participating in this study becomes pregnant, the treating physician must be
             notified immediately; WOCBP must have a negative serum or urine pregnancy test within
             7 days prior to initiating study treatment

          -  No other active malignancy

          -  Ability to understand and the willingness to sign written informed consent and Health
             Insurance Portability and Accountability Act (HIPAA) documents

        Exclusion Criteria:

          -  Patients who have had intravesicular therapy within 4 weeks of study entry, or those
             who have not recovered from adverse effects of such agents administered more than 4
             weeks earlier

          -  Patients may not be receiving any investigational agents within 4 weeks of study entry

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to gemcitabine or cisplatin or other agents used in the study

          -  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

          -  Pregnant women are excluded from this study

          -  Known human immunodeficiency virus (HIV)-positive patients on combination
             antiretroviral therapy are ineligible

          -  Patients who have undergone prior radiation to greater than or equal to 25% of the
             bone marrow within the past year are excluded

          -  Patients who have received any previous systemic chemotherapy or radiation therapy for
             urothelial carcinoma within 1 year of study entry are ineligible