Clinical trial NCT00003701 (phase 3, status: completed)
Conditions: bladder cancer, urethral cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: carboplatin, cisplatin, doxorubicin hydrochloride, methotrexate, paclitaxel, vinblastine sulfate
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [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, [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, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the
        bladder or mixed histologies containing a component of transitional cell carcinoma Must
        have undergone radical cystectomy and pelvic lymph node dissection within 12 weeks prior to
        randomization No evidence of distant metastatic disease on pre- or postoperative
        radiographic scans No positive surgical margins in the cystectomy specimen and no known
        macroscopic residual disease left at time of cystectomy No bladder sparing surgery May have
        undergone continent urinary diversion or neobladder procedure but must have recovered
        completely from the effects of surgery Must have muscle-invasive disease on final
        pathologic staging and have a primary tumor stage of pT4, any N, M0, or any pT, N+, M0, or
        pT3b, any N, any M, and following a pelvic lymph node dissection have a pathologic nodal
        stage of pN0 (only if pT3b or pT4), pN1, or pN2 Clinically unsuspected organ confined
        prostate cancer found during cystoprostatectomy allowed

        PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-2 Life expectancy: Not
        specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
        Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater
        than 2 times ULN Renal: Creatinine no greater than 1.7 mg/dL OR Creatinine clearance at
        least 60 mL/min Cardiovascular: No second degree atrioventricular block or bundle branch
        block Other: No history of prior malignancy in the past 5 years except basal or squamous
        cell carcinoma of the skin or carcinoma in situ of the cervix No active infection requiring
        antibiotics No history of allergic reaction to drugs utilizing the vehicle Cremophor Not
        pregnant or nursing Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY: Recovered from all prior therapies Biologic therapy: No prior
        biologic response modifier therapy No filgrastim (G-CSF) 24 hours pre- or post-chemotherapy
        administration Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not
        specified Radiotherapy: No prior radiotherapy as a component of bladder sparing therapy No
        prior adjuvant radiotherapy for locally advanced disease with positive margins Surgery: See
        Disease Characteristics Other: Prior intravesical therapy for superficial bladder cancer
        allowed and recovered