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
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.
Interventional
Primary Purpose: Treatment
Dean F. Bajorin, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000065305
NCT00002919
November 1996
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |