Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma

Inclusion Criteria:

• Histologic diagnosis of transitional cell carcinoma (TCC) of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required

• All patients must have received only one prior systemic chemotherapy regimen for advanced or metastatic disease (which must have included at least one of the following chemotherapy agents: cisplatin, carboplatin, paclitaxel, docetaxel or gemcitabine), with progression documented during or after that treatment; neoadjuvant as well as adjuvant combination chemotherapy is considered a systemic chemotherapy; radiosensitizing single agent chemotherapy is not considered prior systemic therapy

• Patients must have completed radiotherapy (RT) or chemotherapy >= 4 weeks prior to registration on this trial; patients must have recovered from previous treatments or returned to their baseline in the judgment of the enrolling physician

• No Prior treatment with PS-341 or other proteasome inhibitors

• No prior treatment with investigational agents as single agent therapy; however, the incorporation of an investigational agent into the prior systemic chemotherapy regimen is allowed

• Patients must have measurable disease;

• Measurable Disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as >10 mm with spiral CT scan

• Non-measurable disease: Patients with ONLY non-measurable disease are not eligible for this trial

• Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, which include the following:

• Bone lesions;

• Leptomeningeal disease;

• Ascites;

• Pleural/pericardial effusion;

• Inflammatory breast disease;

• Lymphangitis cutis/pulmonis;

• Abdominal masses that are not confirmed and followed by imaging techniques;

• Cystic lesions

• Primary bladder masses

• CTC (ECOG) performance status =< 2

• Patients must have =< grade 1 peripheral neuropathy at baseline

• No known active brain metastases; patients may not have evidence of active brain metastases; screening CT or MRI is not required, unless there is clinical suspicion of brain metastases

• Pregnant and/or nursing women are not eligible for this trial as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study; pregnant and/or nursing women are not eligible for this trial as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study

• Creatinine =< 2.5 mg/dl or measured or calculated creatinine clearance > 30 ml/min)

• ALT and AST =< 2.5 x ULN

• Total bilirubin =< 1.8 mg/dL

• Granulocytes >= 1500/mm^3

• Platelets >= 100,000/mm^3

• Hemoglobin >= 8 g/dl