Clinical trial NCT00055601 (phase 2, status: completed)
Conditions: bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: cisplatin, fluorouracil, paclitaxel, gemcitabine
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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed operable primary muscle invasive bladder cancer

               -  T2-T4a, NX or N0, M0 (stage II or III)

          -  Must have an adequate functioning bladder

          -  Must have undergone a prior transurethral resection of the bladder tumor within the
             past 8 weeks

          -  No evidence of tumor-related hydronephrosis

          -  No evidence of distant metastases or histologically or cytologically confirmed lymph
             node metastases

          -  Patients with involvement of the prostatic urethra with transitional cell cancer that
             was visibly completely resected are allowed

               -  No evidence of stromal invasion of the prostate

        PATIENT CHARACTERISTICS:

        Age

          -  Not specified

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Hemoglobin at least 10 g/dL

          -  White blood cell (WBC) count at least 4,000/mm^3

          -  Absolute neutrophil count at least 1,800/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Serum bilirubin no greater than 2.0 mg/dL

        Renal

          -  Serum creatinine no greater than 1.5 mg/dL

          -  Creatinine clearance at least 60 mL/min NOTE: If the creatinine clearance is greater
             than 60 mL/min, creatinine of no greater than 1.8 mg/dL is allowed at the discretion
             of the study chair

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer, stage T1a
             prostate cancer, or carcinoma in situ of the cervix

          -  Must be able to tolerate systemic chemotherapy with pelvic radiotherapy and radical
             cystectomy

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior systemic chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior pelvic radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  No concurrent drugs that have potential nephrotoxicity or ototoxicity (e.g.,
             aminoglycosides)