A Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin and Gemcitabine for Regionally Advanced or Metastatic Urothelial Cancer

Inclusion Criteria:

- Biopsy-proven, regionally advanced (T4b, N2, N3), or metastatic (M1) urothelial
cancer of the bladder, ureter, or renal pelvis

- A minimum of one target lesion according to the RECIST criteria (Appendix D). Note:
Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions,
lymphangitic spread or cystic lesions are not acceptable as target lesions.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Appendix
B).

- Age >/=18 years or the age of majority in the state of the participating institution.

- Women of childbearing potential must have a negative pregnancy test and must be
willing to consent to using effective contraception while on treatment and for a
reasonable period thereafter. Post menopausal women must have been amenorrheic for
at least 12 months to be considered of non-childbearing potential.

- An expected survival of at least four months.

- Adequate organ and marrow function as defined as follows:

- leukocytes >/=3,000/µl,

- absolute neutrophil count >/=1,500/µl,

- hemoglobin >/=8.0g/dl,

- platelets >/=100,000/µl,

- total bilirubin and serum creatinine must be < 1.5 mg/dl

- liver transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional ULN if
alkaline phosphatase is
- alkaline phosphatase may be up to 4 x ULN if transaminases are
- Patients who have undergone previous radiation therapy or surgery may be enrolled
into the study but such treatment must have been completed 4 or more weeks prior to
entry to the study and the patient must have recovered. Further, patients who have
undergone radiotherapy may not have received radiation to > 25% of the bone marrow.
Previous intravesicular immunotherapy and chemotherapy are allowed.

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- Undergone previous systemic chemotherapy.

- Major surgery <4 weeks prior to study treatment start, or lack of complete recovery
from major surgery.

- Participation in any investigational drug study within 4 weeks preceding treatment
start.

- History of uncontrolled seizures, central nervous system disorders or psychiatric
disability judged by the Investigator to be significant enough to preclude informed
consent or interfering with compliance for oral drug intake.

- Previous history of cancer unless treatment was curative and completed >/=5 years
prior to entry onto study, or unless diagnosed as one of the following: in situ
carcinoma (any location), basal cell carcinoma, or non-metastatic squamous cell
carcinoma of the skin.

- Uncontrolled intercurrent illness including, but not limited to: ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris,
uncontrolled or untreated cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.

- Pregnant women are excluded from this study because of the teratogenic potential of
cisplatin and gemcitabine. Lactating women are also excluded. (Should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately.)

- Peripheral neuropathy >/= grade 2.