Bladder CancerPhase 3NCT00003814
Eflornithine in Treating Patients With Bladder Cancer
A Phase 3 study testing eflornithine in people with Bladder Cancer, run by National Cancer Institute (NCI) at 61 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if eflornithine is more effective than no further therapy in treating 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?
- eflornithine
- How many people
- 450 participants
- Where
- 61 sitesUnited States
- Study dates
- Feb 1999to May 2007
- Phase
- Phase 3
- 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 low grade (grade 1 or 2), superficial (stage Ta or T1) transitional cell carcinoma (TCC) of the bladder Newly diagnosed or recurrent All visible tumor must have been resected within the past 12 weeks Standard clinical management determined to be expectant observation without further surgery, intravesical therapy, or systemic therapy No prior upper tract TCC No history of grade 3 TCC, carcinoma in situ including severe dysplasia, non-TCC histology, or TCC greater than or equal to T2 No involvement of upper urinary tract prior to or at the time of initial tumor resection Abdominal CT scan, IVP, or retrograde pyelogram within the past 3 months to rule out upper urinary tract tumor
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior malignancy within the past 5 years and no concurrent malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No clinically significant hearing loss (i.e., hearing loss effects everyday life and/or wears a hearing aide) No other significant medical or psychiatric condition
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior growth factors No concurrent growth factors Chemotherapy: No prior systemic chemotherapy for bladder cancer No concurrent intravesical therapy At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior high dose steroids or prednisone No concurrent high dose steroids No concurrent prednisone or its equivalent in excess of 10 mg/day Radiotherapy: No prior radiotherapy for bladder cancer At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since prior carbamazepine or experimental drugs No concurrent carbamazepine or experimental drugs
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
Cancer Center of Albany Medical Center
Albany, New York, 12208
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
University Hospital of New Mexico
Albuquerque, New Mexico, 87106
St. Joseph West Mesa Center
Albuquerque, New Mexico, 87114
Advanced Urology Medical Center
Anaheim, California, 92801
Piedmont Urology PC
Atlanta, Georgia, 30309
Georgia Urology
Atlanta, Georgia, 30342
Medical & Clinical Research Associates, LLC
Bay Shore, New York, 11706
Urology Associates
Birmingham, Alabama, 35205
Lahey Clinic - Burlington
Burlington, Massachusetts, 01805
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Tampa Bay Meical Research
Clearwater, Florida, 33761
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
Urology Clinics of North Texas
Dallas, Texas, 75231
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
University of North Texas HSC
Fort Worth, Texas, 76107
University of Florida - Gainesville
Gainesville, Florida, 32610-0277
Citrus Valley Urological Medical Group
Glendora, California, 91741-4164
206 Research Associates
Greenbelt, Maryland, 20770
Intouch Research
Huntsville, Alabama, 35801
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
San Diego Urology Center
La Mesa, California, 91942
South Coast Urological Medical Group
Laguna Hills, California, 92653
Office of Sheldon Freedman
Las Vegas, Nevada, 89109
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Urology Associates, Inc.
Marietta, Georgia, 30060
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Urology Health Center
New Port Richey, Florida, 34652
Mount Sinai Medical Center, NY
New York, New York, 10029
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
Foothill Urology Associates
Pasadena, California, 90024
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Allegheny University of the Health Sciences
Philadelphia, Pennsylvania, 19119
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
Oregon Cancer Center
Portland, Oregon, 97201-3098
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 97213-2967
Virginia Urology Center
Richmond, Virginia, 23230
University of Rochester Cancer Center
Rochester, New York, 14642
Mid Atlantic Clinical Research
Rockville, Maryland, 20850
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Urology San Antonio Research
San Antonio, Texas, 78229
San Bernadino Urological Associates
San Bernadino, California, 92404
DRC and Urological Physicians of San Diego
San Diego, California, 92103
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center
Sarasota, Florida, 34239
Seattle Urological Associates
Seattle, Washington, 98104-1360
Urology Northwest PS
Seattle, Washington, 98133
University of Washington Medical Center
Seattle, Washington, 98195-6043
Urology Surgical Associates
Springfield, Missouri, 65804
Washington University Barnard Cancer Center
St Louis, Missouri, 63110
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Urology Specialists, P.C.
Waterbury, Connecticut, 06708
Wichita Clinic, P.A.
Wichita, Kansas, 67208
Fallon Clinic, Inc.
Worcester, Massachusetts, 01605
About this study
Official title: Phase III Randomized, Double-Blind Study of DFMO vs. Placebo in Low Grade Superficial Bladder Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if eflornithine is more effective than no further therapy in treating bladder cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in treating patients who have newly diagnosed or recurrent bladder cancer.
Read the detailed description
OBJECTIVES: I. Determine whether treatment with eflornithine is effective in preventing recurrence of tumor after transurethral resection in patients with low grade, superficial transitional cell carcinoma of the bladder. II. Determine the incidence and severity of toxicities associated with the long-term use of this drug in this patient population.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified according to disease status (newly diagnosed vs recurrent), clinical stage (Ta vs T1), grade (G1 vs G2), and focus (multifocal vs unifocal). Patients receive either oral eflornithine or placebo once daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months during the first 2 years, every 6 months for the third year, and then annually for the fourth year.
PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued to this study within 1.5 years.
- Conditions
- Bladder Cancer
- Being tested
- eflornithine
- Keywords
- stage 0 bladder cancer, stage I bladder cancer, recurrent 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.
eflornithineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2004 (estimated)
- Study startFeb 1999
- Study completionMay 2007
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 National Cancer Institute (NCI)The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Mark Mayle, Study chair, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003814
- Sponsor's protocol ID
- CDR0000066966
- Other IDs
- ILEX-DFMO341, UCLA-9812049, UF-453-1998, WCCC-CO-98803, NCI-G99-1509
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-Blind Study of DFMO vs. Placebo in Low Grade Superficial Bladder Cancer
- ClinicalTrials.gov ID
- NCT00003814
- Acronym / sponsor ID
- CDR0000066966
- Conditions
- Bladder Cancer
- Keywords
- stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 1999
- Study completion
- May 2007 (actual)
- First posted
- 20 Feb 2004 (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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if eflornithine is more effective than no further therapy in treating bladder cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in treating patients who have newly diagnosed or recurrent bladder cancer.
Detailed description
OBJECTIVES: I. Determine whether treatment with eflornithine is effective in preventing recurrence of tumor after transurethral resection in patients with low grade, superficial transitional cell carcinoma of the bladder. II. Determine the incidence and severity of toxicities associated with the long-term use of this drug in this patient population.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified according to disease status (newly diagnosed vs recurrent), clinical stage (Ta vs T1), grade (G1 vs G2), and focus (multifocal vs unifocal). Patients receive either oral eflornithine or placebo once daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months during the first 2 years, every 6 months for the third year, and then annually for the fourth year.
PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued to this study within 1.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
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 |
|---|---|---|
| eflornithine | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Dec 2013.
Related trials for Bladder Cancer
Not yet recruiting
Remote Screening and Navigation to Increase Trial Enrollment, INVITE Trial
Bladder Carcinoma, Prostate Carcinoma
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Malignant Neoplasms, Hereditary Neoplastic Syndromes
Active, not recruiting
An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers
Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Mark Mayle study chair
Genzyme, a Sanofi Company
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eflornithine in people with Bladder Cancer, run by National Cancer Institute (NCI) at 61 sites in United States.
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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 18 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.