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
18 Years
N/A
Both
Bladder Cancer
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Invasive transitional cell carcinoma of the bladder that is
clinical stage T2-3a N0 M0 by cystoscopy Cystoscopy performed at Memorial Sloan-Kettering
Cancer Center (MSKCC) No multifocal carcinoma in situ No obstructive uropathy or palpable
mass Pathologic confirmation of histology and no more than 20% positive expression of
nuclear p53, as follows: On study following transurethral resection of the bladder (TURB)
OR At TURB performed within 6 weeks of entry as part of initial staging
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%
Hematopoietic: WBC at least 3,500 Platelets greater than 150,000 Hepatic: Bilirubin less
than 2.0 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than
60 mL/min per 1.73 square meters Cardiovascular: No NYHA class III/IV status Other: No
concomitant malignancy other than basal cell skin carcinoma Negative pregnancy test
required of fertile women Adequate contraception required of fertile women
PRIOR CONCURRENT THERAPY: No prior systemic chemotherapy No prior bladder irradiation
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Dean F. Bajorin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000065305
NCT ID:
NCT00002919
Start Date:
November 1996
Completion Date:
Related Keywords:
- Bladder Cancer
- stage II bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
