Tipifarnib in Treating Patients With Recurrent Bladder Cancer

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have recurrent bladder cancer.

OBJECTIVES:

* Determine the 1-year recurrence-free survival rate of patients with stage 0 or I recurrent transitional cell carcinoma of the bladder treated with tipifarnib.

OUTLINE: This is a multicenter study.

Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study within 18 months.

Eligibility 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