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Tipifarnib in Treating Patients With Recurrent Bladder Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00047216
Enrollment
Unknown
Registered
2003-01-27
Start date
2002-11-30
Completion date
Unknown
Last updated
2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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

DRUGtipifarnib

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University Health Network, Toronto
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
1-year recurrence-free survival

Secondary

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026