MedPath

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

Phase 3
Conditions
Bladder Cancer
Registration Number
NCT00003725
Lead Sponsor
Anthra Pharmaceuticals
Brief 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. 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (52)

Urology Associates

🇺🇸

Birmingham, Alabama, United States

Urology Associates, Ltd.

🇺🇸

Phoenix, Arizona, United States

University of California San Diego Cancer Center

🇺🇸

La Jolla, California, United States

San Diego Urology Center

🇺🇸

San Diego, California, United States

Hillcrest Urological Medical Group

🇺🇸

San Diego, California, United States

UCSF Cancer Center and Cancer Research Institute

🇺🇸

San Francisco, California, United States

Santa Monica Urologic Medical Group

🇺🇸

Santa Monica, California, United States

Western Urological Associates

🇺🇸

Van Nuys, California, United States

Urology Specialists, P.C.

🇺🇸

Waterbury, Connecticut, United States

George Washington University Hospital

🇺🇸

Washington, District of Columbia, United States

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Urology Associates
🇺🇸Birmingham, Alabama, United States

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