Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven progressive regional or metastatic
transitional cell carcinoma of the urothelium or mixed histology containing a component of
transitional cell carcinoma Failure of only 1 prior chemotherapy regimen for metastatic
disease or in the adjuvant or neoadjuvant setting (not containing taxane or gemcitabine)
Bidimensionally measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
75,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times
upper limit of normal (ULN) if alkaline phosphatase normal OR Alkaline phosphatase no
greater than 4 times ULN if SGOT normal OR SGOT less than 1.5 times ULN AND alkaline
phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 1.8 mg/dL
Cardiovascular: No American Heart Association class III or IV heart disease No
uncontrolled congestive heart failure No severe cardiac arrhythmias Neurologic: No sensory
neuropathy grade 3 or 4 No prior peripheral neuropathy grade 2 or worse Other: No active
unresolved infection being treated with parenteral antibiotics within the past 7 days No
other malignancy within the past 5 years except: Curatively treated basal or squamous cell
skin cancer or carcinoma in situ of the cervix Clinically unsuspected, organ confined
prostate cancer found during cystoprostatectomy Not pregnant or nursing Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier
therapy Prior intravesical BCG allowed Chemotherapy: See Disease Characteristics Endocrine
therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At
least 4 weeks since prior major surgery and recovered