Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Any age	NCI	MDA-ID-01317 NCT00080795

Special Category: SPORE trial

Objectives

Primary

1. 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

1. Compare perioperative morbidity and mortality of patients treated with this regimen vs historical standards.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

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

Expected Enrollment

A total of 31-49 patients will be accrued for this study within 16-25 months.

Outcomes

Response rate
Disease-free survival at 4 years

Comparison of perioperative treatment morbidity and mortality with 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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Randall Millikan, MD, PhD, Protocol chair		Ph: 713-563-7245; 800-392-1611 Email: rmillika@mdanderson.org
Colin Dinney, MD, Protocol co-chair		Ph: 713-792-3250; 800-392-1611

Registry Information
Official Title		Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer
Trial Start Date		2001-07-24
Registered in ClinicalTrials.gov		NCT00080795
Date Submitted to PDQ		2003-11-11
Information Last Verified		2006-08-07
NCI Grant/Contract Number		CA16672, CA91846

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