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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00080795

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer	Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Drug: ifosfamide Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase 2

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer

Study Start Date :

Jul 1, 2001

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Response rate [6 weeks following treatment]
Disease-free survival at 4 years [4 years]

Secondary Outcome Measures

Comparison of perioperative treatment morbidity and mortality with historical standards [Minimally reviewed following 6 weeks post treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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