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Surgery + Chemotherapy for Bladder Cancer

Phase 3

Waitlist Available

Research Sponsored by Anthra Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have at least 2 papillary appearing bladder tumors by cystoscopic examination

Patients with recurrent disease must have no history of Tis tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying transurethral resection followed by AD 32 to see how well it works compared with transurethral resection alone in treating patients with bladder cancer.

Who is the study for?

This trial is for adults with newly diagnosed or recurrent superficial bladder cancer who have at least two tumors visible by cystoscopy. They should not be pregnant, must use contraception if fertile, and have no history of certain types of bladder tumor (Tis). Participants need normal blood counts and liver/renal function tests, and they shouldn't have had prior treatments like chemotherapy or radiotherapy for bladder cancer.Check my eligibility

What is being tested?

The study is testing the effectiveness of a less invasive surgery called transurethral resection alone versus the same surgery followed by a chemotherapy drug named AD 32 in treating patients with early-stage or recurrent bladder cancer. It's a phase III trial where participants are randomly assigned to one of these two approaches.See study design

What are the potential side effects?

While specific side effects for AD 32 aren't listed here, common side effects from similar chemotherapy drugs include nausea, fatigue, increased risk of infection due to low blood cell counts, hair loss, and potential damage to organs such as the kidneys or liver.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least 2 bladder tumors that look like papillary.

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My cancer has come back, but I've never had a Tis tumor.

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My liver function tests are within twice the normal range.

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It has been over 9 months since my bladder surgery.

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My bladder cancer is in the early or recurrent superficial stage.

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My kidney function, measured by creatinine, is within normal limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Anthra PharmaceuticalsLead Sponsor

1 Previous Clinical Trials

Peter R. Carroll, MDStudy ChairUniversity of California, San Francisco

3 Previous Clinical Trials

2,618 Total Patients Enrolled

Media Library

Transurethral Resection Clinical Trial Eligibility Overview. Trial Name: NCT00003725 — Phase 3

Bladder Cancer Clinical Trial 2023: Transurethral Resection Highlights & Side Effects. Trial Name: NCT00003725 — Phase 3

Transurethral Resection 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003725 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators looking for more participants in this experiment?

"The clinical trial hosted on clinicaltrials.gov is not recruiting patients at this time, as seen in the last update from 11/5/2013. However, there are other 393 trials that are actively looking for participants."

Answered by AI

In how many hospitals is this study being conducted?

"The study's 54 different locations include Urology Health Center in New Port Richey, Florida, Urology Associates in Birmingham, Alabama, and Western Urological Associates in Van Nuys, California."

Answered by AI

What is the governing body's opinion on this medication?

"This treatment option has been deemed safe by our team at Power, who gave it a score of 3. This is because the treatment is currently in Phase 3 trials, which means that there is some data supporting its efficacy and multiple rounds of data supporting safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

1996. "Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00003725.

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