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

Phase 2

Completed

• Conditions: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

• Registration Number: NCT00080795
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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 Timeline

• Study Start: 2001-07
• Study First Submitted: 2004-04-07
• Study First Submitted QC: 2004-04-07
• Study First Posted: 2004-04-08
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-18
• Last Update Posted: 2012-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	6 weeks following treatment
Disease-free survival at 4 years	4 years

Secondary Outcome Measures

Name	Time	Method
Comparison of perioperative treatment morbidity and mortality with historical standards	Minimally reviewed following 6 weeks post treatment

Trial Locations

Locations (1)

M.D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States