NCT00047216

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2002

Completed
29 days until next milestone

Study Start

First participant enrolled

November 1, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

3.3 years

First QC Date

October 3, 2002

Last Update Submit

July 22, 2015

Conditions

Bladder Cancer

Keywords

recurrent bladder cancerstage 0 bladder cancerstage I bladder cancertransitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

  • 1-year recurrence-free survival

Secondary Outcomes (5)

  • 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

Interventions

tipifarnibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 355, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Sunnybrook and Women's College Health Sciences Centre

North York, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Joseph Chin, MD

    London Health Sciences Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

November 1, 2002

Primary Completion

March 1, 2006

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CA(5)US(2)