Clinical trial NCT00072150 (phase 2, status: completed)
Conditions: metastatic transitional cell cancer of the renal pelvis and ureter, recurrent bladder cancer, recurrent transitional cell cancer of the renal pelvis and ureter, recurrent urethral cancer, stage iii bladder cancer, stage iii urethral cancer, stage iv bladder cancer, stage iv urethral cancer, transitional cell carcinoma of the bladder, ureter 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: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        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