Bladder Cancer Clinical Trial
Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium
Summary
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, doxorubicin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works in treating patients undergoing radical cystectomy for locally advanced carcinoma of the urothelium.
Full Description
OBJECTIVES:
Primary
Determine the response rate and 4-year disease-free survival of patients with locally advanced carcinoma of the urothelium undergoing radical cystectomy treated with neoadjuvant chemotherapy comprising ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide.
Secondary
Compare perioperative morbidity and mortality of patients treated with this regimen vs historical standards.
OUTLINE: Patients receive neoadjuvant chemotherapy comprising ifosfamide IV over 3 hours on days 1-4, doxorubicin IV on day 3, gemcitabine IV over 30 minutes on days 2 and 4, and filgrastim (G-CSF) subcutaneously on days 7-12 or until blood counts recover. Treatment repeats every 3 weeks for a total of 3 courses. Patients then receive cisplatin IV, gemcitabine IV over 90 minutes, and ifosfamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for a total of 4-6 courses. Four to six weeks after the completion of all neoadjuvant chemotherapy, patients undergo cystectomy.
Patients are followed at 9, 12, 15, 18, 24, and 30 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 31-49 patients will be accrued for this study within 16-25 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the urothelium, meeting 1 of the following criteria for locally advanced disease:
Clinical stage T3b disease, defined by presence of a mass on examination under anesthesia
Clinical stage T4a disease, defined by direct invasion of prostatic stroma, vagina, or rectum
Lymphovascular invasion on transurethral resection specimen
Upper tract disease or micropapillary histology allowed
No evidence of disease outside the pelvis
PATIENT CHARACTERISTICS:
Age
Any age
Performance status
0-2
Life expectancy
Not specified
Hematopoietic
Bone marrow function adequate
Hepatic
Liver function adequate
Renal
Creatinine clearance ≥ 45 mL/min
Cardiovascular
Ejection fraction ≥ 50%
Other
Not pregnant
No other malignancy likely to be life-threatening within the next 4 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
See Disease Characteristics
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There is 1 Location for this study
Houston Texas, 77030, United States
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