Tipifarnib in Treating Patients With Recurrent Bladder Cancer

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Bladder Cancer

Treatments: Drug: tipifarnib

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00047216

NCI-5612

PMH-PHL-007

CDR0000257564 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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