Bladder Cancer Clinical Trial
Official title:
PHASE II TRIAL OF THE COMBINATION OF TRANSURETHRAL RESECTION AND NEOADJUVANT CHEMOTHERAPY FOR PATIENTS WITH INVASIVE UROTHELIAL TRACT TUMORS SELECTED BY STAGE AND P53 NUCLEAR EXPRESSION
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following
surgery in treating patients with stage II bladder cancer.
OBJECTIVES: I. Determine the efficacy of combination chemotherapy with methotrexate,
vinblastine, doxorubicin, and cisplatin (MVAC) following aggressive transurethral resection
of bladder tumors in patients with stage II transitional cell carcinoma of the bladder
without nuclear overexpression of mutant p53. II. Determine the proportion of patients
treated with this regimen in whom bladder preservation rather than radical cystectomy is
possible.
OUTLINE: All patients undergo complete or near complete transurethral resection of the
bladder tumor at entry or within 6 weeks prior to entry. Upon confirmation of staging and
histology, patients receive combination chemotherapy with methotrexate, vinblastine,
doxorubicin, and cisplatin (MVAC) every 21 days for 4 courses. Subcutaneous G-CSF is given
with each course. Patients with a complete response after chemotherapy proceed to
intravesical therapy or observation; those with a partial response, stable disease, or
progression proceed to definitive surgery.
PROJECTED ACCRUAL: 30 patients will be entered over approximately 18 months.
;
Primary Purpose: Treatment
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