Status:
COMPLETED
Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Eligibility:
All Genders
Phase:
PHASE2
Brief 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...
Detailed 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 neoadjuvan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00080795
Start Date
July 1 2001
End Date
May 1 2006
Last Update
October 22 2012
Active Locations (1)
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1
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009