Tipifarnib in Treating Patients With Recurrent Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047216
• Other study ID #: PMH-PHL-007
• Secondary ID: CDR0000257564NCI
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2002
• Last updated: July 22, 2015
• Start date: November 2002

Study information

• Verified date: July 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms

Intervention

Drug:
• tipifarnib

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital	Hamilton	Ontario
Canada	London Regional Cancer Program at London Health Sciences Centre	London	Ontario
Canada	Sunnybrook and Women's College Health Sciences Centre	North York	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year recurrence-free survival			No
Secondary	Recurrence rate at 3, 6, 9, and 12 months			No
Secondary	Progression rate at 3, 6, 9, and 12 months			No
Secondary	Survival rate			No
Secondary	Time to treatment failure			No
Secondary	Molecular changes in the host tissue			No