Clinical trial · Interventional
Tipifarnib in Treating Patients With Recurrent Bladder Cancer
A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder
NCT00047216CI-TRIAL-00018617completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 1-year recurrence-free survival
Secondary outcomes (5)
- measure
- Recurrence rate at 3, 6, 9, and 12 months
- measure
- Progression rate at 3, 6, 9, and 12 months
- measure
- Survival rate
- measure
- Time to treatment failure
- measure
- Molecular changes in the host tissue
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.