Clinical trial NCT00055835 (phase 2, 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, gemcitabine hydrochloride, paclitaxel
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, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, [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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary or recurrent invasive carcinoma of the urothelium

               -  Transitional, squamous, or mixed cell subtypes allowed

               -  Primary disease site must be the urinary bladder or urethra

               -  Disease confined to the true pelvis (T2-T4, N0-N3, M0)

               -  Must meet at least 1 of the following criteria:

                    -  Nodal involvement at or below the level of the bifurcation of the iliac
                       vessels

                    -  Medically or surgically inoperable

                    -  Patient refused cystectomy

          -  Measurable or nonmeasurable disease

          -  Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed
             bladder mapping within the past 56 days

          -  No extrapelvic metastases

          -  Eligible to receive radiotherapy

               -  Planned radiotherapy at a SWOG-approved facility

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least lower limit of normal

        Hepatic

          -  Bilirubin no greater than upper limit of normal (ULN)

          -  SGOT or SGPT no greater than 2.5 times ULN

        Renal

          -  Creatinine clearance at least 60 mL/min OR

          -  Creatinine no greater than ULN

        Gastrointestinal

          -  No chronic diarrhea

          -  No malabsorption

          -  No extensive diverticular disease of the colon

          -  No inflammatory bowel disease

          -  No other pre-existing gastrointestinal disorders

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No active infections requiring antibiotics

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer currently in complete remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for patients with a current diagnosis of advanced bladder cancer
             that is also the initial diagnosis

          -  No prior systemic chemotherapy except adjuvant therapy for recurrent disease completed
             more than 6 months ago

          -  No prior carboplatin

          -  No prior paclitaxel

          -  No prior gemcitabine

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  No prior pelvic radiotherapy

        Surgery

          -  See Disease Characteristics

          -  Recovered from prior surgery