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Tipifarnib in Treating Patients With Recurrent Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tipifarnib
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • Vancouver General Hospital
  • St. Joseph's Hospital
  • London Regional Cancer Program at London Health Sciences Centre
  • Sunnybrook and Women's College Health Sciences Centre
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

1-year recurrence-free survival

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2002
Last Updated
July 22, 2015
Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00047216
Brief Title
Tipifarnib in Treating Patients With Recurrent Bladder Cancer
Official Title
A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
recurrent bladder cancer, stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tipifarnib
Primary Outcome Measure Information:
Title
1-year recurrence-free survival
Secondary Outcome Measure Information:
Title
Recurrence rate at 3, 6, 9, and 12 months
Title
Progression rate at 3, 6, 9, and 12 months
Title
Survival rate
Title
Time to treatment failure
Title
Molecular changes in the host tissue

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Chin, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 355
Country
Canada
Facility Name
St. Joseph's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Sunnybrook and Women's College Health Sciences Centre
City
North York
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Tipifarnib in Treating Patients With Recurrent Bladder Cancer

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