Clinical Trial Detail

Genders Eligible for Study: Both

- Age 18 years and older at the time of consent

- Histologically documented metastatic or locally inoperable advanced TCC of the urinary tract (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3 or M1 disease) NOTE: Certain mixed histologies that are predominately (> or = to 50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires IHC consistent with a TCC origin. Mixed small-cell histologies are excluded.

- Measurable disease defined as at least one target lesion that has not been irradiated and can be accurately measured in at least one dimension by RECIST 1.1 criteria

- No prior systemic chemotherapy with the following exceptions:

- 1) Prior use of radiosensitizing single agent therapy is allowed

- 2) Prior neoadjuvant and adjuvant chemotherapy may be allowed

- Minimum of 21 days since prior major surgery or radiation therapy

- Karnofsky performance status > or = to 70%

- Required laboratory values at baseline:

- 1) ANC > or = to 1.5x1^9 cells/L

- 2) platelet count > or = to 125 x 1^9/

- 3) Calculated creatinine clearance > or = to 60 mL/minute

- 4) bilirubin < or = to 1.5 x ULN (< or = to 2.5 x ULN if secondary to Gilbert's disease)

- 5) AST and ALT < or = to 3.0 x ULN

- If of child-bearing potential, willing to use contraceptives

- Willing to give written informed consent

Other eligibility criteria may apply.

- Intravesical therapy within the last 3 months

- Documented brain metastasis or carcinomatous meningitis, treated or untreated. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of CNS disease.

- Peripheral neuropathy > or = to Grade 2

- Known serious hypersensitivity to gemcitabine, cisplatin or carboplatin

- Current serious, uncontrolled medical condition such as congestive heart failure, angina, hypertension, arrhythmia, diabetes mellitus, infection, etc. or any condition such as a psychiatric illness which in the opinion of the investigator would make the patient unacceptable for the protocol

- Cerebrovascular accident, myocardial infarction or pulmonary embolus within 6 months of randomization

- Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study

- Pregnant or nursing (must have a negative serum or urine pregnancy test within 72 hours prior to randomization)

- Participating in a concurrent clinical trial of an experimental drug, vaccine or device. Participation in an observational study is allowed.

Other exclusion criteria may apply.