Clinical trial NCT00005047 (phase 3, status: terminated)
Conditions: bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: cisplatin, doxorubicin hydrochloride, methotrexate, vinblastine
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, 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, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    accrual was halted on the basis of the data and safety monitoring board review of a futility
    analysis.
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven organ confined transitional cell carcinoma (TCC) of the bladder

               -  Must have undergone radical cystectomy and bilateral pelvic lymphadenectomy with
                  pathologic stage from definitive cystectomy specimen of P1, P2a, or P2b and N0,
                  M0 TCC with or without squamous/glandular differentiation (no adenocarcinoma,
                  squamous cell carcinoma, or small cell carcinoma)

                    -  Margins must be negative for invasive or in situ TCC

                    -  In situ TCC in the urethra or ureter(s) allowed provided margins are
                       negative

               -  Clinical stage T1, T2a, or T2b based on transurethral resection bladder tumor
                  specimen with P0 or PIS and N0, M0 TCC allowed

               -  Incidental pT2a (Gleason score no greater than 7), pT2b (Gleason score no greater
                  than 7), or pT2c (Gleason score no greater than 7) adenocarcinoma of the prostate
                  allowed

          -  No invasive tumor into ureter(s) or urethra

          -  Must have potentially curable disease

          -  Must register within 9 weeks after surgery

          -  No metastatic disease by physical exam and chest x-ray or CT scan of the chest

          -  Eligible for randomization if:

               -  p53 gene alteration present

               -  Randomization occurs within 10 weeks after surgery

               -  Those who are randomized to receive (MVAC) methotrexate, vinblastine,
                  doxorubicin, and cisplatin begin MVAC within 12 weeks after cystectomy

               -  No metastatic disease by physical exam and chest x-ray or CT scan of the chest

               -  No prohibitive medical risk for chemotherapy

        PATIENT CHARACTERISTICS:

        Age

          -  Any age

        Performance status

          -  ECOG 0-1 OR

          -  Karnofsky 70-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC at least 4,000/mm^3

          -  Platelet count at least 150,000/mm^3

        Hepatic

          -  SGOT or SGPT no greater than 2 times normal

          -  Alkaline phosphatase no greater than 2 times normal

          -  Bilirubin normal

        Renal

          -  Creatinine no greater than 1.8 mg/dL OR

          -  Creatinine clearance at least 50 mL/min

          -  Blood urea nitrogen normal

        Cardiovascular

          -  No serious arrhythmias

          -  No congestive heart disease with New York Heart Association class III or IV status

          -  Randomization group:

               -  Ejection fraction must be at least 50% by MUGA scan if there is a clinical
                  concern regarding the patient's cardiac status

        Other

          -  No other malignancy (including synchronous papillary or invasive upper urinary tract
             malignancy) within the past 5 years except incidental prostate cancer (found at
             cystectomy), basal cell or squamous cell skin cancer, or carcinoma in situ of the
             cervix

          -  No concurrent advanced medical illness or psychologic disease

          -  No prohibitive medical risk for chemotherapy

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

          -  No prior systemic chemotherapy for bladder cancer

          -  At least 5 years since other prior systemic chemotherapy

          -  Prior intravesical therapy allowed

          -  Randomization group:

               -  Prior intravesical therapy allowed if administered prior to cystectomy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior pelvic irradiation

        Surgery

          -  See Disease Characteristics