Bladder CancerPhase 2NCT00047216
Tipifarnib in Treating Patients With Recurrent Bladder Cancer
A Phase 2 study testing tipifarnib in people with Bladder Cancer, run by University Health Network, Toronto at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- tipifarnib
- How many people
- Not given
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2002to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada5 sites
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Vancouver General Hospital
Vancouver, British Columbia, V5Z 355
United States2 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
About this study
Official title: A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder
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.
Read the 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
- Being tested
- tipifarnib
- Keywords
- recurrent bladder cancer, stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tipifarnibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 2002
- Primary completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joseph Chin, MD, Study chair, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047216
- Sponsor's protocol ID
- PMH-PHL-007
- Other IDs
- CDR0000257564, NCI-5612
- Status last verified
- Jul 2015
- First submitted
- 3 Oct 2002
- Last updated
- 23 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder
- ClinicalTrials.gov ID
- NCT00047216
- Acronym / sponsor ID
- PMH-PHL-007
- Conditions
- Bladder Cancer
- Keywords
- recurrent bladder cancer, stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2002
- Primary completion
- Mar 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tipifarnib | Drug | – |
Primary outcome
1-year recurrence-free survival
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Chin, MD study chair
London Health Sciences Centre
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tipifarnib in people with Bladder Cancer, run by University Health Network, Toronto at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence-free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.