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Tipifarnib in Treating Patients With Recurrent Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047216
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 23, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: tipifarnib Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder
Study Start Date : November 2002
Actual Primary Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Primary Outcome Measures :
  1. 1-year recurrence-free survival

Secondary Outcome Measures :
  1. Recurrence rate at 3, 6, 9, and 12 months
  2. Progression rate at 3, 6, 9, and 12 months
  3. Survival rate
  4. Time to treatment failure
  5. Molecular changes in the host tissue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 1 year


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN)


  • Creatinine no greater than 1.25 times ULN OR
  • Creatinine clearance at least 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension


  • 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


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No prior systemic chemotherapy for bladder cancer

Endocrine therapy

  • Not specified


  • No prior radiotherapy for bladder cancer


  • See Disease Characteristics


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00047216

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United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 355
Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
National Cancer Institute (NCI)
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Study Chair: Joseph Chin, MD London Health Sciences Centre
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Responsible Party: University Health Network, Toronto Identifier: NCT00047216    
Other Study ID Numbers: PMH-PHL-007
CDR0000257564 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015
Keywords provided by University Health Network, Toronto:
recurrent bladder cancer
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents