Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Doxorubicin; Gemcitabine; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin

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