Bladder CancerPhase 3NCT00003725
Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
A Phase 3 study testing valrubicin and conventional surgery in people with Bladder Cancer, run by Anthra Pharmaceuticals at 53 sites in 2 countries.
Trial summary
RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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?
- valrubicin and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 53 sitesin 2 countries
- Study dates
- Dec 1996to not given
- 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 diagnosed stage 0 (Ta), stage I, or recurrent superficial transitional cell carcinoma of the bladder Must have at least 2 papillary appearing bladder tumors by cystoscopic examination Patients with recurrent disease must have no history of Tis tumor
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 4000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biological response modifiers for bladder cancer Chemotherapy: No prior or concurrent chemotherapy for bladder cancer No prior AD 32 therapy for bladder cancer Endocrine therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy Surgery: At least 9 months since any complete transurethral resection of the bladder
Trial locations and contacts
53 sites in 2 countries.
53 sites in 2 countries
United States51 sites
Urology Associates of North Texas
Arlington, Texas, 76015
Georgia Urology
Atlanta, Georgia, 30342
Urology Associates
Birmingham, Alabama, 35205
Cambridge Urological Associates, Inc.
Cambridge, Massachusetts, 02238
Affliated Urology
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Department of Urology and Urologic Oncology
Columbus, Ohio, 43210
Atlantic Urological Associates
Daytona Beach, Florida, 32114
Michigan Institute of Urology
Detroit, Michigan, 48236
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
University of Florida - Gainesville
Gainesville, Florida, 32610-0277
Baylor College of Medicine
Houston, Texas, 77030
Mississippi Urology Clinic, P.A.
Jackson, Mississippi, 39202
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
San Diego Urology Center
La Mesa, California, 91942
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, 78236-5300
Sheldon Freedman Ltd.
Las Vegas, Nevada, 89109
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
Clinic of Urologic Wellness
Lexington, Kentucky, 40509
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Urology Care - South
Miami, Florida, 33173
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9162
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
Urology Health Center
New Port Richey, Florida, 34652
Office of John Byrne
New Rochelle, New York, 10801
Mount Sinai Medical Center, NY
New York, New York, 10029
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Sentara Cancer Center
Norfolk, Virginia, 23507
Desert Urology
North Las Vegas, Nevada, 89128
Office of Ira W. Klimberg
Ocala, Florida, 32674
Urology Center
Omaha, Nebraska, 68122
Urology Associates, Ltd.
Phoenix, Arizona, 85012
Office of Jeffrey K. Cohen
Pittsburgh, Pennsylvania, 15222
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098
Urology Clinic, P.C.
Portland, Oregon, 97210
Wake Urological Associates
Raleigh, North Carolina, 27607
Virginia Urology Center
Richmond, Virginia, 23230
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
Hillcrest Urological Medical Group
San Diego, California, 92103
San Diego Urology Center
San Diego, California, 92120
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
Santa Monica Urologic Medical Group
Santa Monica, California, 90404
Urology Treatment Center
Sarasota, Florida, 3429
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
Office of Ronald G. Anderson
Tacoma, Washington, 98405
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
Western Urological Associates
Van Nuys, California, 91405
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Urology Specialists, P.C.
Waterbury, Connecticut, 06708
Canada2 sites
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Phase III Randomized Study of a Single Adjunctive Instillation of Intravesical AD 32 (N-Trifluoroacetyladriamycin-14-valerate) Versus No Adjunctive Therapy Immediately Following Transurethral Resection in Patients With Multiple Superficial (Ta/T1) Bladder Tumors
RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether transurethral resection plus AD 32 is more effective than transurethral resection alone for bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer.
Read the detailed description
OBJECTIVES: I. Assess the efficacy of adjuvant AD 32 following complete transurethral resection versus transurethral resection alone in patients with newly diagnosed or recurrent superficial transitional cell carcinoma of the bladder. II. Assess the toxicity of AD 32 in these patients.
OUTLINE: This is an open label, randomized, multicenter study. Patients are randomized to receive surgery with AD 32 or surgery alone. Arm I: Patients undergo surgery to remove bladder tumors. AD 32 is administered by catheter into the bladder within 2-24 hours after surgery. Patients must hold the AD 32 liquid in the bladder for 90 minutes. Arm II: Patients undergo only surgery to remove bladder tumors. Patients with T1 or Tis disease may receive BCG therapy once weekly for 6 weeks, followed by 6 weeks of rest. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: This study will accrue approximately 300 patients.
- Conditions
- Bladder Cancer
- Being tested
- valrubicin, conventional surgery
- 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.
valrubicinDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2004 (estimated)
- Study startDec 1996
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.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anthra Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter R. Carroll, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003725
- Sponsor's protocol ID
- CDR0000066837
- Other IDs
- ANTHRA-A9601
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of a Single Adjunctive Instillation of Intravesical AD 32 (N-Trifluoroacetyladriamycin-14-valerate) Versus No Adjunctive Therapy Immediately Following Transurethral Resection in Patients With Multiple Superficial (Ta/T1) Bladder Tumors
- ClinicalTrials.gov ID
- NCT00003725
- Acronym / sponsor ID
- CDR0000066837
- 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
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Anthra PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 1996
- First posted
- 22 Jul 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: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether transurethral resection plus AD 32 is more effective than transurethral resection alone for bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer.
Detailed description
OBJECTIVES: I. Assess the efficacy of adjuvant AD 32 following complete transurethral resection versus transurethral resection alone in patients with newly diagnosed or recurrent superficial transitional cell carcinoma of the bladder. II. Assess the toxicity of AD 32 in these patients.
OUTLINE: This is an open label, randomized, multicenter study. Patients are randomized to receive surgery with AD 32 or surgery alone. Arm I: Patients undergo surgery to remove bladder tumors. AD 32 is administered by catheter into the bladder within 2-24 hours after surgery. Patients must hold the AD 32 liquid in the bladder for 90 minutes. Arm II: Patients undergo only surgery to remove bladder tumors. Patients with T1 or Tis disease may receive BCG therapy once weekly for 6 weeks, followed by 6 weeks of rest. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: This study will accrue approximately 300 patients.
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 |
|---|---|---|
| valrubicin | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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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.
Peter R. Carroll, MD study chair
University of California, San Francisco
53 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing valrubicin and conventional surgery in people with Bladder Cancer, run by Anthra Pharmaceuticals at 53 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: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Canada. 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?
Results are not available in the source record.
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 6 Nov 2013.