Tipifarnib in Treating Patients With Recurrent Bladder Cancer

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00047216

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Drug: tipifarnib	Phase 2

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 Design

Study Type:

Interventional

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 :

Nov 1, 2002

Actual Primary Completion Date :

Mar 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

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