Tipifarnib in Treating Patients With Recurrent Bladder Cancer

NCT ID: NCT00047216

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30

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.

Conditions

Bladder Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

tipifarnib

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Chin, MD

Role: STUDY_CHAIR

London Health Sciences Centre

Locations

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Louis A. Weiss Memorial Hospital

Chicago, Illinois, United States

Vancouver General Hospital

Vancouver, British Columbia, 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

Countries

United States; Canada

Other Identifiers

CDR0000257564

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-5612

Identifier Type: -

Identifier Source: secondary_id

PMH-PHL-007

Identifier Type: -

Identifier Source: org_study_id