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Tipifarnib in Treating Patients With Recurrent Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00047216
First received: October 3, 2002
Last updated: July 23, 2008
Last verified: March 2005
  Purpose

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 Intervention Phase
Bladder Cancer
Drug: tipifarnib
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 1-year recurrence-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence rate at 3, 6, 9, and 12 months [ Designated as safety issue: No ]
  • Progression rate at 3, 6, 9, and 12 months [ Designated as safety issue: No ]
  • Survival rate [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Molecular changes in the host tissue [ Designated as safety issue: No ]

Study Start Date: November 2002
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047216

Locations
United States, Illinois
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 355
Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Study Chair: Joseph Chin, MD London Regional Cancer Program at London Health Sciences Centre
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00047216     History of Changes
Other Study ID Numbers: CDR0000257564, PMH-PHL-007, NCI-5612
Study First Received: October 3, 2002
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Tipifarnib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014