Bladder Cancer
Conditions
Keywords
recurrent bladder cancer, stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate at 3, 6, 9, and 12 months | — |
| Progression rate at 3, 6, 9, and 12 months | — |
| Survival rate | — |
| Time to treatment failure | — |
| Molecular changes in the host tissue | — |
Countries
Canada, United States