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.

Condition	Treatment or Intervention	Phase
stage II bladder cancer transitional cell carcinoma of the bladder	Drug: cisplatin  Drug: doxorubicin  Drug: filgrastim  Drug: methotrexate  Drug: vinblastine	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• No prior systemic chemotherapy; No prior bladder irradiation

--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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Dean F. Bajorin,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000065305; MSKCC-96066; NCI-H97-1118
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002919
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08