Clinical trial NCT01094964 (phase 3, status: unknown status)
Conditions: bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: epirubicin hydrochloride, mitomycin c
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, CO[C@]12[C@H]3N[C@H]3CN1C1=C([C@H]2COC(N)=O)C(=O)C(N)=C(C)C1=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of non-muscle invasive bladder cancer

          -  Recurrent disease after undergoing induction or maintenance therapy with bacillus
             Calmette-Guérin (BCG), meeting any 1 of the following criteria:

               -  Stage Ta or T1 disease (grade 2 or 3)

               -  Carcinoma in situ with stage Ta or T1 disease (grade 1, 2, or 3)

               -  Carcinoma in situ alone

          -  Has undergone a second resection of all T1 disease to exclude muscle invasive disease

          -  No urothelial cell carcinoma (UCC) ≥ T2

          -  No recurrence of grade 1 UCC following BCG induction therapy

          -  No UCC involving the prostatic urethra or upper urinary tract

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-4

          -  WBC ≥ 3.0 x 10^9/L

          -  Absolute neutrophil count ≥ 1.5 x 10^9/L

          -  Hemoglobin ≥ 10 g/dL

          -  Platelet count ≥ 100 x 10^9/L

          -  Serum creatinine < 1.5 times upper limit of normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Normal kidneys and ureters on imaging CT scan within the past 12 months

          -  Available for long-term follow-up with a life expectancy of the duration of the trial

          -  Must be fit and willing to undergo a full or partial cystectomy

          -  No known or suspected reduced bladder capacity (< 250 mL)

          -  No significant bleeding disorder

          -  No other malignancy within the past 5 years except nonmelanomatous skin cancer cured
             by excision, adequately treated carcinoma in situ of the cervix, or DCIS/LCIS of the
             breast

          -  No known allergy to mitomycin or bacillus Calmette-Guérin (BCG), or previously
             withdrawn from BCG treatment due to a related adverse event (e.g., systemic infection)

          -  No active or intractable urinary tract infection

          -  No urethral stricture or any situation impeding the insertion of a 20F catheter

          -  No bladder diverticula > 1 cm

          -  No significant urinary incontinence

          -  No concurrent implanted electronic devices (e.g., cardiac pacemakers) or metallic
             implants within the pelvis, lower torso, spine, hip, or upper femur

          -  No immunocompromised state for any reason

        PRIOR CONCURRENT THERAPY:

          -  At least 6 months since prior intravesical chemotherapy, except for single
             instillation post-transurethral resection

          -  No prior pelvic irradiation

          -  No prior hyperthermia in combination with intravesical mitomycin

          -  Concurrent participation in other studies allowed

          -  No current or long-term use of corticosteroids

          -  No concurrent chemotherapy