A Phase II Trial of R115777, an Oral Farnesyltransferase Inhibitor (FTI) in Previously Untreated Patients With Advanced Urothelial Tract Transitional Cell Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the
urothelial tract not curable by surgery or radiotherapy Bladder, renal pelvis, or ureter
Stage II, III, or IV (T2-4, N0-3, M0-1) with unresectable disease Poorly differentiated
transitional cell carcinoma or predominant transitional cell carcinoma with foci of
squamous differentiation or rare foci of adenocarcinoma allowed No adenocarcinoma, small
cell carcinoma, sarcoma, or squamous cell carcinoma Bidimensionally measurable disease No
disease confined to the bladder only No soft tissue disease irradiated within the past 2
months No known active CNS disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet
count greater than 100,000/mm3 Hepatic: SGOT no greater than 2 times upper limit of normal
(ULN) Bilirubin normal Renal: Creatinine no greater than 2 times ULN Other: No unresolved,
active bacterial infection requiring antibiotics No other prior malignancy within the past
5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in
situ of the cervix, or adequately treated stage I or II cancer in complete remission Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent myeloid colony stimulating
factors Chemotherapy: At least 12 months since prior adjuvant or neoadjuvant chemotherapy
and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since
prior surgery and recovered Other: No prior systemic therapy (including investigational
agents) for metastatic bladder cancer At least 4 weeks since prior intravesical therapy
and recovered At least 30 days since prior participation in other investigational drug
trial No concurrent intravesical therapy No other concurrent therapy for cancer