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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080795
• Other study ID #: CDR0000355361
• Secondary ID: MDA-ID-01317ID01
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2004
• Last updated: October 18, 2012
• Start date: July 2001
• Est. completion date: May 2006

Study information

• Verified date: October 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Ureteral Neoplasms
• Urethral Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• cisplatin

• doxorubicin hydrochloride

• gemcitabine hydrochloride

• ifosfamide

Procedure:
• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		6 weeks following treatment	No
Primary	Disease-free survival at 4 years		4 years	No
Secondary	Comparison of perioperative treatment morbidity and mortality with historical standards		Minimally reviewed following 6 weeks post treatment	No