Tipifarnib in Treating Patients With Recurrent Bladder Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed transitional cell carcinoma (TCC) of the bladder with or without associated carcinoma in situ
• •* Stage 0 or I (Ta or T1)
• •* Grade 1, 2, or 3 TCC
• •Cystoscopically and histologically confirmed recurrent disease after at least 1 course of standard first-line intravesical therapy (e.g., BCG or mitomycin) within the past 12 months
• •Complete transurethral resection of bladder tumor performed within past 4 weeks
• •* Rendered clinically and cystoscopically tumor free
• •* Negative cytology
• •No upper tract TCC by intravenous pyelogram, retrograde pyelogram, or CT scan of kidneys (with contrast)
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-2 OR
• •Karnofsky 60-100%
• •Life expectancy
• •More than 1 year
• •Hematopoietic
• •WBC at least 3,000/mm\^3
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic
• •Bilirubin normal
• •AST/ALT no greater than 2.5 times upper limit of normal (ULN)
• •Renal
• •Creatinine no greater than 1.25 times ULN OR
• •Creatinine clearance at least 60 mL/min
• •Cardiovascular
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •No uncontrolled hypertension
• •Other
• •Able to swallow and retain oral medication
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No prior allergic reactions to compounds of similar chemical or biological composition to study drug (e.g., other imidazoles such as ketoconazole and other imidazole-based antifungal agents, losartan, metronidazole, or cimetidine)
• •No other prior or concurrent malignancy within the past 5 years except nonmelanomatous skin cancer
• •No other uncontrolled concurrent illness that would preclude study participation
• •No ongoing or active infection
• •No active peptic ulcer disease
• •No psychiatric illness or social situation that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •See Disease Characteristics
• •No prior systemic chemotherapy for bladder cancer
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •No prior radiotherapy for bladder cancer
• •Surgery
• •See Disease Characteristics
• •Other
• •No single-dose post-transurethral resection (TUR) adjuvant intravesical therapy (after TUR that is performed immediately preceding study entry)
• •At least 4 weeks since prior investigational agents
• •No concurrent commercial or other investigational agents or therapies for malignancy
• •No other concurrent therapy for bladder cancer
• •No concurrent combination anti-retroviral therapy for HIV-positive patients