Clinical trial NCT00047216: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: recurrent bladder cancer
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 1-year recurrence-free survival
Secondary outcomes:
measure: Recurrence rate at 3, 6, 9, and 12 months
measure: Progression rate at 3, 6, 9, and 12 months
measure: Survival rate
measure: Time to treatment failure
measure: Molecular changes in the host tissue
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Chicago
country: United States
facility: Louis A. Weiss Memorial Hospital
state: Illinois
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program at London Health Sciences Centre
state: Ontario
city: North York
country: Canada
facility: Sunnybrook and Women's College Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Joseph Chin, MD
role: STUDY_CHAIR
References: