Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer
N/A
N/A
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Trial Information
Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
6 weeks following treatment
Safety Issue:
No
Principal Investigator
Randall E. Millikan, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000355361
NCT ID:
NCT00080795
Start Date:
July 2001
Completion Date:
May 2006
Related Keywords:
- Bladder Cancer
- Transitional Cell Cancer of the Renal Pelvis and Ureter
- Urethral Cancer
- stage III bladder cancer
- regional transitional cell cancer of the renal pelvis and ureter
- anterior urethral cancer
- posterior urethral cancer
- urethral cancer associated with invasive bladder cancer
- Urinary Bladder Neoplasms
- Urethral Neoplasms
- Carcinoma, Transitional Cell
- Kidney Neoplasms
- Ureteral Neoplasms
Name | Location |
|---|---|
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
