Tipifarnib in Treating Patients With Recurrent Bladder Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: tipifarnib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tipifarnib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year recurrence-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent bladder cancer, stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder