A Phase II Study of Oxaliplatin in Urothelial Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic urothelial
carcinoma Bidimensionally measurable disease Platinum sensitive OR platinum resistant
Platinum sensitive disease: No prior platinum containing regimen OR Progressive or
recurrent disease more than 6 months after responding to a platinum containing regimen
Platinum resistant disease: Progressive or recurrent disease within 6 months of a platinum
containing regimen (cisplatin or carboplatin) No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100%
Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal
SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater
than 2.0 mg/dL OR Creatinine clearance at least 30 mL/min Cardiovascular: No uncontrolled
concurrent illness including, but not limited to: Symptomatic congestive heart failure
Unstable angina pectoris Cardiac arrhythmia Other: No clinical evidence of neuropathy
worse than grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception during and for 6 months after study No allergy to platinum
compounds or antiemetics No uncontrolled concurrent illness including, but not limited to,
an active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors
during the first course of study therapy Chemotherapy: See Disease Characteristics One
prior chemotherapy regimen for metastatic disease allowed Prior neoadjuvant or adjuvant
chemotherapy regimen allowed if the interval between this therapy and the first therapy
for metastatic disease was at least 6 months At least 4 weeks since prior chemotherapy
Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy
Surgery: Not specified Other: No other concurrent investigational agents No HIV positive
patients receiving antiretroviral therapy