Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Tipifarnib in Treating Patients With Recurrent Bladder Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI PMH-PHL-007 NCI-5612, NCT00047216, 5612

Objectives

1. 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.

Entry 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)

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

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/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 37 patients will be accrued for this study within 18 months.

Outcomes

1-year recurrence-free survival

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

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.

Trial Contact Information

Trial Lead Organizations

Princess Margaret Hospital

Joseph Chin, MD, Protocol chair		Ph: 519-685-8451 Email: JCHIN@lhsc.on.ca

Registry Information
Official Title		A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder
Trial Start Date		2002-11-01
Registered in ClinicalTrials.gov		NCT00047216
Date Submitted to PDQ		2002-08-15
Information Last Verified		2005-03-28
NCI Grant/Contract Number		CM17107

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