Clinical trial NCT00112905 (phase 2, status: terminated)
Conditions: adenocarcinoma of the bladder, distal urethral cancer, metastatic transitional cell cancer of the renal pelvis and ureter, proximal urethral cancer, recurrent bladder cancer, recurrent transitional cell cancer of the renal pelvis and ureter, recurrent urethral cancer, regional transitional cell cancer of the renal pelvis and ureter, squamous cell carcinoma of the bladder, stage iii bladder cancer, stage iv bladder cancer, transitional cell carcinoma of the bladder, urethral cancer associated with invasive bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4, D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: sorafenib tosylate
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed transitional cell carcinoma or mixed histologies containing a
             component of transitional cell carcinoma of the urothelium (renal pelvis, ureter,
             bladder, urethra) with manifestations of progressing regional or metastatic cancer; or
             (2) Nontransitional cell histologies include patients with adenocarcinoma or squamous
             cell carcinomas representing greater than 90% of specimen; patients with small cell
             carcinoma, soft tissue sarcomas, or carcinosarcomas are excluded

          -  Measurable disease, as defined in the RECIST criteria; all sites of disease must be
             evaluated within 4 weeks prior to registration

          -  Patients must have progressed on one and only one prior systemic chemotherapy for
             metastatic disease; prior chemotherapy administered in the adjuvant or neoadjuvant
             setting is permitted (i.e. does not count as 1 prior regimen) provided that it was
             completed greater than 12 months prior to the start of the first chemotherapy regimen
             administered in the metastatic setting

          -  Patients must not have had prior systemic biologic response modifier therapy; patients
             must not have had chemotherapy, hormonal or biologic therapy within 4 weeks (6 weeks
             for nitrosoureas or mitomycin C) prior to entering the study or have recovered from
             adverse events due to agents administered more than 4 weeks earlier

          -  Prior radiotherapy is allowed; patients must be >= 2 weeks post-radiotherapy at time
             of registration; a previously irradiated lesion can only be used as a marker lesion if
             there is unequivocal evidence of progression demonstrated on serial imaging studies;
             patients must have recovered from all toxicities associated with prior radiotherapy

          -  Patients must be >= 4 weeks post-major surgery at time of registration; patients must
             have recovered from all toxicities associated with prior surgery

          -  ECOG performance status of 0 or 1

          -  No history of severe cardiovascular disease (AHA Class III or IV), uncontrolled CHF,
             uncontrolled hypertension, or ventricular dysrhythmias

          -  Patients with previously resected and irradiated CNS metastases with evidence of
             stable disease are eligible

          -  Patients with a history of prior malignancy are eligible provided they were treated
             with curative intent and have been disease free for >= 5 years; curatively treated
             basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix
             must have been treated with curative intent; patients with clinically unsuspected
             organ confined prostate cancer found at the time of cystoprostatectomy are eligible

          -  Creatinine < 1.5 mg/dL

          -  Granulocytes >= 1500/mm^3

          -  Platelets >= 100,000/mm^3

          -  AST =< 2.5 x institutional upper limit of normal

          -  Bilirubin < 1.5 mg/dl

          -  No active unresolved infection requiring parenteral antibiotics < 7 days prior to
             study entry

          -  Patients must not have a swallowing dysfunction which would prevent the ingesting of
             pills

          -  Patients must not have any evidence of bleeding diathesis

          -  Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation
             (i.e. low dose warfarin) of venous or arterial access devices is allowed provided that
             the requirements for PT, INR or PTT are met

          -  Patients must not be taking the cytochrome P450 enzyme-inducing antiepileptic drugs
             (phenytoin, carbamazepine, and phenobarbital), rifampin, or St. John's Wort

          -  Women of childbearing potential must not be pregnant (as proven by a negative
             pregnancy test within 14 days prior to registration) or breast feeding because the
             effects of this treatment on the fetus and breast-fed infants is unknown

          -  Women of childbearing potential and sexually active males must be strongly advised to
             use an accepted and effective method of contraception