Tipifarnib in Treating Patients With Recurrent Bladder Cancer

July 22, 2015 updated by: University Health Network, Toronto

A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 355
        • Vancouver General Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program at London Health Sciences Centre
      • North York, Ontario, Canada, M4N 3M5
        • Sunnybrook and Women's College Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60640
        • Louis A. Weiss Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
1-year recurrence-free survival

Secondary Outcome Measures

Outcome Measure
Time to treatment failure
Survival rate
Recurrence rate at 3, 6, 9, and 12 months
Progression rate at 3, 6, 9, and 12 months
Molecular changes in the host tissue

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Joseph Chin, MD, London Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 23, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMH-PHL-007
  • CDR0000257564 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-5612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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