Tipifarnib in Treating Patients With Recurrent Bladder Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: National Cancer Institute (NCI)
• Treatments: Tipifarnib

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